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Ethinyl Estradiol / Ferrous Fumarate / Norethindrone

Ethinyl estradiol, norethindrone and ferrous fumarate is a combination birth control pill (an estrogen plus a progestin, with iron-containing reminder tablets) used to prevent pregnancy, and some products are also used for moderate acne.

Brand names Lo Loestrin FeJunel Fe 28 DayJunelTarina 24 FeHailey Fe 1.5/30 +11 more
Drug class Estrogen
Rx
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 52 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 3, 2026
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written
This combination pill is a well-established way to prevent pregnancy, and some products also treat moderate acne. It works best when taken at the same time every day. Do not smoke while on it, and talk with your doctor about clot, heart and stroke risks first.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Cigarette smoking raises the risk of serious heart and blood vessel problems, such as heart attack and stroke, in women who take birth control pills. The risk goes up with age and with the number of cigarettes smoked. It is especially high for women over 35 and heavy smokers (15 or more cigarettes a day). Women over 35 who smoke should not use this pill, and all pill users are strongly advised not to smoke.

Your risk is also higher if you have high blood pressure, diabetes, high cholesterol, or a history of clots, heart attack, stroke, angina, breast cancer, jaundice or liver tumors. Do not take the pill if you might be pregnant or have unexplained vaginal bleeding.

Read the full warning on DailyMed →
How you get itPrescription only
Earliest FDA record2003
Companies listing it with the FDA27
FDA label last updatedFeb 20, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Ethinyl Estradiol / Ferrous Fumarate / Norethindrone, written from its FDA label.

What Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is used for

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This combination is used mainly for birth control, and some products have an added use.

  • Preventing pregnancy: all products, including Junel, Loestrin and Xarah Fe, in women who choose oral contraceptives.
  • Moderate acne vulgaris: the norethindrone acetate, ethinyl estradiol and ferrous fumarate tablet kit and Xarah Fe, in females 15 and older who have started their periods, want birth control, and have not responded to topical acne medicines.
  • For acne, the pill should be used only if you plan to stay on it for at least 6 months.

How Ethinyl Estradiol / Ferrous Fumarate / Norethindrone works

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The pill mainly works by stopping ovulation. It also thickens cervical mucus so sperm have a harder time entering the uterus. It changes the uterine lining so implantation is less likely.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone dosage

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You take one pill by mouth daily at about the same time. Most 28-day packs have 21 active pills followed by 7 reminder pills, and you start the next pack the day after the last reminder pill. Some products can be taken without regard to meals.

  • You can start on Day 1 of your period or on the Sunday after it starts. With a Sunday start, use back-up birth control for the first 7 days.
  • If you miss one active pill, take it as soon as you remember and take the next at your regular time.
  • If you miss two or more active pills, extra steps and back-up birth control are needed. Check your pack insert or call your doctor or clinic.
  • If you miss a reminder pill in week 4, throw it away and keep going. No back-up is needed.

Dosing details from the FDA-approved label

From the Ethinyl Estradiol / Ferrous Fumarate / Norethindrone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • 21-Day Dosage Regimen (Junel 21), Sunday-Start
    • One tablet daily for 21 consecutive days followed by one week of no tablets (7 days)
    • Begins taking tablets from the top row on the first Sunday after menstrual flow begins
    • For all subsequent cycles begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet
    • Use an additional method of protection until after the first week of administration in the initial cycle; tablets at intervals not exceeding 24 hours
  • 21-Day Dosage Regimen (Junel 21), Day-1 Start
    • One tablet daily beginning with the first tablet in the top row on Day 1 of menstrual flow, for 21 tablets, then no tablets for a week (7 days)
    • A new 21-tablet regimen begins on the eighth day after taking her last tablet
    • Tablets should be taken regularly with a meal or at bedtime
  • 28-Day Dosage Regimen (Junel Fe), Sunday-Start
    • One light yellow or pink tablet daily for 21 days, then without interruption one brown tablet daily for 7 days
    • A second course begins the next day (Sunday)
    • Brown ferrous fumarate tablets are non-hormone containing and do not serve any therapeutic purpose; taken at intervals not exceeding 24 hours
  • Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, general use
    • One tablet by mouth at the same time every day for 28 days, in the order directed on the blister pack
    • The tablet may be chewed and swallowed or swallowed whole, followed by a full glass (8 ounces) of water
    • May be administered without regard to meals; tablets should not be skipped or taken at intervals exceeding 24 hours
  • Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets, Day 1 Start
    • One white tablet daily for 24 consecutive days beginning on Day 1 of the menstrual cycle, followed by one brown ferrous fumarate tablet daily on days 25 through 28
    • Use a non-hormonal back-up contraceptive during the first 7 days if starting on a day other than the first day of the menstrual cycle
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION The tablet dispenser has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in either three or four rows of seven tablets each, with the days of the week appearing on the tablet dispenser above the first row of tablets. Note: Each tablet dispenser has been preprinted with the days of the week, starting with Sunday, to facilitate a Sunday-Start regimen. Six different days of the week stickers have been provided with the Detailed Patient & Brief Summary Patient Package Insert in order to accommodate a Day 1 Start regimen. If the patient is using the Day 1 Start regimen, she should place the self-adhesive days of the week sticker that corresponds to her starting day over the preprinted days. Important: The patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle when utilizing the Sunday-Start regimen. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage and Administration for 21 Day Dosage Regimen To achieve maximum contraceptive effectiveness, Junel ® 21 must be taken exactly as directed and at intervals not exceeding 24 hours. Junel ® 21 provides the patient with a convenient tablet schedule of “3 weeks on --1 week off”. Two dosage regimens are described, one of which may be more convenient or suitable than the other for an individual patient. For the initial cycle of therapy, the patient begins her tablets according to the Day 1 Start or Sunday-Start regimen. With either regimen, the patient takes one tablet daily for 21 consecutive days followed by one week of no tablets. 1. Sunday Start Regimen: The patient begins taking tablets from the top row on the first Sunday after menstrual flow begins. When menstrual flow begins on Sunday, the first tablet is taken on the same day. The last tablet in the dispenser will then be taken on a Saturday, followed by no tablets for a week (7 days). For all subsequent cycles, the patient then begins a new 21-tablet regimen on the eighth day, Sunday, after taking her last tablet. Following this regimen, of 21 days on--7 days off, the patient will start all subsequent cycles on a Sunday. 2. Day 1 Regimen: The first day of menstrual flow is Day 1.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone side effects

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Common side effects

  • Nausea or vomiting
  • Spotting or light bleeding between periods
  • Stomach cramps and bloating
  • Changes in menstrual flow, or missed periods
  • Breast tenderness or enlargement
  • Weight change
  • Swelling (edema)
  • Mood changes

When to get medical help

  • Call your doctor or get urgent help for signs of a blood clot, heart attack or stroke, since these pills raise those risks.
  • Get medical help right away if you have sudden partial or complete vision loss, bulging eyes, double vision, or swelling of the optic nerve.
  • Call your doctor if you develop yellowing of the skin or eyes (jaundice).
  • Tell your doctor if your blood pressure rises, or if you have depression or migraines that are new or getting worse.
  • Call your doctor if you miss your period two months in a row, because you could be pregnant.
  • Tell your doctor if spotting or nausea does not go away after the first 1 to 3 packs.

Many women have spotting, light bleeding or nausea in the first 1 to 3 packs. These usually go away.

  • Nausea or vomiting
  • Spotting or breakthrough bleeding
  • Cramps and bloating
  • Changes in menstrual flow or missed periods
  • Breast tenderness
  • Weight change and swelling
  • Mood changes

Call your doctor for signs of blood clots, stroke, heart attack, vision changes, jaundice or high blood pressure.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone warnings and precautions

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The biggest risk is serious heart and blood vessel problems in women who smoke, especially those over 35.

  • Higher risk of heart attack, blood clots, stroke, liver tumors and gallbladder disease.
  • Risk rises with high blood pressure, high cholesterol, obesity and diabetes.
  • Stop and get help for sudden vision loss, double vision or bulging eyes.
  • It does not protect against HIV or other sexually transmitted infections.
  • Vomiting, diarrhea or certain medicines can lower its effectiveness.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone interactions

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Some medicines can make the pill work less well, and the pill can change levels of other drugs.

  • Rifampin: speeds up breakdown of the hormones and can cause bleeding.
  • Phenobarbital, phenytoin, carbamazepine: may lower effectiveness.
  • Troglitazone: lowers hormone levels.
  • Antibiotics such as ampicillin, tetracycline and griseofulvin: pregnancies have been reported, so use a back-up method.
  • Hepatitis C drugs with ombitasvir/paritaprevir/ritonavir: must not be combined, because of liver enzyme rises.
  • Cyclosporine, prednisolone, theophylline: levels may increase.
  • Acetaminophen, temazepam, salicylic acid, morphine: levels or clearance may change.

Interactions listed in the FDA-approved label

From the Ethinyl Estradiol / Ferrous Fumarate / Norethindrone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased, with reduced contraceptive effectiveness and increased breakthrough bleeding and menstrual irregularities.
  • Anticonvulsants (phenobarbital, phenytoin, carbamazepine): Increase the metabolism of ethinyl estradiol and/or norethindrone, which could reduce contraceptive effectiveness.
  • Troglitazone: Reduced the plasma concentrations of both ethinyl estradiol and norethindrone by approximately 30%, which could reduce contraceptive effectiveness.
  • Antibiotics (ampicillin, tetracycline, griseofulvin): Pregnancy has been reported with concomitant use, but pharmacokinetic studies have not shown any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids.
  • Atorvastatin: Increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively.
  • HCV combination therapy containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir: Potential for ALT elevations. Co-administration is contraindicated.
  • Glecaprevir/pibrentasvir: Potential for ALT elevations. Co-administration is not recommended.
  • Ascorbic acid and acetaminophen: May increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation.
  • Phenylbutazone: A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding has been suggested.
  • Cyclosporine, prednisolone, theophylline: Increased plasma concentrations have been reported with concomitant oral contraceptive use.
Read the label’s full interactions text

7. Drug Interactions Effects of Other Drugs on Oral Contraceptives (69) Rifampin: Metabolism of both norethindrone and ethinyl estradiol is increased by rifampin. A reduction in contraceptive effectiveness and increased incidence of breakthrough bleeding and menstrual irregularities have been associated with concomitant use of rifampin. Anticonvulsants : Anticonvulsants such as phenobarbital, phenytoin, and carbamazepine, have been shown to increase the metabolism of ethinyl estradiol and/or norethindrone, which could result in a reduction in contraceptive effectiveness. Troglitazone: Administration of troglitazone with an oral contraceptive containing ethinyl estradiol and norethindrone reduced the plasma concentrations of both by approximately 30%, which could result in a reduction in contraceptive effectiveness. Antibiotics: Pregnancy while taking oral contraceptives has been reported when the oral contraceptives were administered with antimicrobials such as ampicillin, tetracycline, and griseofulvin. However, clinical pharmacokinetic studies have not demonstrated any consistent effect of antibiotics (other than rifampin) on plasma concentrations of synthetic steroids. Atorvastatin: Coadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%, respectively. Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Co-administration of Tarina Fe 1/20 EQ with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir is contraindicated due to potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with concomitant Hepatitis C Treatment ). Co-administration of Tarina Fe 1/20 EQ and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations. Other: Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Ethinyl Estradiol / Ferrous Fumarate / Norethindrone

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  • Do not use if you are pregnant or might be.
  • Do not use if you are over 35 and smoke.
  • Tell your doctor about blood clots, stroke, heart disease or heart valve problems.
  • Tell your doctor about uncontrolled high blood pressure or diabetes with complications.
  • Tell your doctor about migraines with aura, or migraines if over 35.
  • Tell your doctor about breast cancer or estrogen-dependent cancer.
  • Tell your doctor about liver tumors or jaundice.
  • Tell your doctor about unexplained vaginal bleeding.
  • Ask about stopping before major surgery or long immobility.
  • After delivery, if not breastfeeding, start no sooner than 4 to 6 weeks.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone overdose

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Serious ill effects have not been reported after young children swallowed large amounts of combined birth control pills. An overdose may cause nausea, and withdrawal bleeding may occur in females.

What Ethinyl Estradiol / Ferrous Fumarate / Norethindrone does in the body

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The combination suppresses gonadotropins (hormones that trigger ovulation). It raises sex hormone binding globulin two- to three-fold and lowers free testosterone by about 47% to 64%, which points to minimal androgen-like activity. For acne, the link between these changes and better skin has not been established.

How your body processes Ethinyl Estradiol / Ferrous Fumarate / Norethindrone

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Both hormones are absorbed quickly, with peak blood levels about 1 to 2 hours after a dose. Norethindrone acetate is converted to norethindrone. Bioavailability is about 64% for norethindrone and 43% for ethinyl estradiol. Both are extensively broken down in the body, and both bind strongly to proteins in the blood.

How to store Ethinyl Estradiol / Ferrous Fumarate / Norethindrone

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Store at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ethinyl Estradiol / Ferrous Fumarate / Norethindrone — the kind of thing our pharmacy team would talk through with you at the counter.

What is this pill used for?

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Its main job is preventing pregnancy. Some versions, like Xarah Fe and certain generic kits, are also approved for moderate acne in females 15 and older who want birth control and haven't improved with skin treatments. For acne, you should plan to stay on it at least 6 months.

How do I take it?

▾
Take one pill by mouth every day at the same time, in the order on your pack. Most 28-day packs have 21 active pills and 7 reminder pills, and you start the next pack the day after the last reminder pill. Following your prescriber's directions and the pack insert matters a lot, since missed pills raise the chance of pregnancy.

What if I miss a pill?

▾
If you miss one active pill, take it as soon as you remember and take the next one at your usual time. If you miss two or more active pills, you may need to use back-up birth control like condoms. Your pack insert has the exact steps, and your pharmacist or doctor can help if you're unsure. Missed reminder pills in week 4 can simply be thrown away.

What side effects should I expect?

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Spotting, light bleeding and nausea are common in the first 1 to 3 packs, and they usually go away. Don't stop the pill because of them. Call your doctor if they continue, or right away for signs of a blood clot, stroke, vision changes or yellow skin or eyes.

Does smoking matter?

▾
Yes, it matters a lot. Smoking while on the pill raises your risk of serious heart and blood vessel problems, especially over age 35. If you are over 35 and smoke, you should not take this pill.

Can other medicines affect it?

▾
Yes. Rifampin and seizure medicines like phenytoin and carbamazepine can make it less effective. Vomiting, diarrhea and some antibiotics may also lower protection, so use a back-up method until you check with your doctor or clinic. Also tell us if you're prescribed a hepatitis C medicine, because some can't be used with this pill.

Is Ethinyl Estradiol / Ferrous Fumarate / Norethindrone available over the counter?

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Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Ethinyl Estradiol / Ferrous Fumarate / Norethindrone first available?

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Ethinyl Estradiol / Ferrous Fumarate / Norethindrone has been available in the United States since at least 2003, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Ethinyl Estradiol / Ferrous Fumarate / Norethindrone?

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Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is supplied by 27 manufacturers listed in the FDA NDC Directory, including Glenmark Pharmaceuticals Inc., USA, Teva Pharmaceuticals USA, Inc., Northstar Rx LLC.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ethinyl Estradiol / Ferrous Fumarate / Norethindrone on HelloPharmacist

Detailed data & references for Ethinyl Estradiol / Ferrous Fumarate / Norethindrone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone on the U.S. market: products, makers and brands

How Ethinyl Estradiol / Ferrous Fumarate / Norethindrone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

27 companies list 130 Ethinyl Estradiol / Ferrous Fumarate / Norethindrone product records with the FDA; the earliest marketing or approval year on record is 2003. Brand names on the directory include Lo Loestrin Fe, Junel Fe 28 Day, Junel and 13 more; the rest are generics.

27
Labelers (makers, repackagers, distributors)
40
Brand names
130
FDA-listed product records ⓘ
2003
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (130) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Glenmark Pharmaceuticals Inc., USA13%
Teva Pharmaceuticals USA, Inc.9%
Northstar Rx LLC8%
Allergan, Inc.8%
Aurobindo Pharma Limited7%
Mylan Pharmaceuticals Inc.5%
Other makers49%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is used (Medicaid data)

A general measure of how commonly Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,023,509
Medicaid prescriptions filled (Q1–Q4 2025)
$91M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ethinyl Estradiol / Ferrous Fumarate / Norethindrone prescribed? Of the 1,600 medications we measure, Ethinyl Estradiol / Ferrous Fumarate / Norethindrone ranks #173 by Medicaid prescriptions — more than 89% of them.

Where Ethinyl Estradiol / Ferrous Fumarate / Norethindrone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ethinyl Estradiol / Ferrous Fumarate / Norethindrone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 34 of 105 listed Ethinyl Estradiol / Ferrous Fumarate / Norethindrone NDCs with Medicaid activity.

Compare Ethinyl Estradiol / Ferrous Fumarate / Norethindrone products

A representative set of FDA-listed product records for Ethinyl Estradiol / Ferrous Fumarate / Norethindrone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 130 of 130 products — FDA National Drug Code Directory. See every product, package size and price: browse all 130 Ethinyl Estradiol / Ferrous Fumarate / Norethindrone NDCs →

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ethinyl Estradiol / Ferrous Fumarate / Norethindrone recalls since July 2021.

✅No Ethinyl Estradiol / Ferrous Fumarate / Norethindrone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone brand names

Ethinyl Estradiol / Ferrous Fumarate / Norethindrone is sold under 16 brand names in the FDA directory — Lo Loestrin Fe, Junel Fe 28 Day, Junel, Tarina 24 Fe and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lo Loestrin Fe Junel Fe 28 Day Junel Tarina 24 Fe Hailey Fe 1.5/30 Microgestin Fe 1.5/30 Microgestin Fe 1/20 Loestrin Tarina Fe 1/20 EQ Larin Fe 1/20 Junel Fe 1/20 Taytulla Charlotte 24Fe Hailey 24 Fe Larin 24 Fe Larin Fe 1.5/30

Who makes Ethinyl Estradiol / Ferrous Fumarate / Norethindrone: manufacturers and labelers

27 companies list Ethinyl Estradiol / Ferrous Fumarate / Norethindrone products with the FDA. By number of product records, the largest are Glenmark Pharmaceuticals Inc., USA, Teva Pharmaceuticals USA, Inc., Northstar Rx LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Glenmark Pharmaceuticals Inc., USA 17 Teva Pharmaceuticals USA, Inc. 12 Northstar Rx LLC 11 Allergan, Inc. 10 Aurobindo Pharma Limited 9 Mylan Pharmaceuticals Inc. 7 RPK Pharmaceuticals, Inc. 7 Amneal Pharmaceuticals NY LLC 6 A-S Medication Solutions 5 Afaxys Pharma, LLC 5 Xiromed, LLC 5 Teva Women's Health LLC 4 Mayne Pharma Inc. 4 Preferred Pharmaceuticals Inc. 4 Proficient Rx LP 3 Amneal Pharmaceuticals LLC 3 Actavis Pharma, Inc. 3 Lupin Pharmaceuticals, Inc. 3 Teva Women's Health, Inc. 2 Naari Pte Limited 2 Xiromed LLC 2 Greenstone LLC 1 Slayback Pharma LLC 1 Bryant Ranch Prepack 1

…and 3 more on the FDA NDC directory.

Sources for this Ethinyl Estradiol / Ferrous Fumarate / Norethindrone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 20, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ethinyl Estradiol / Ferrous Fumarate / Norethindrone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ethinyl Estradiol / Ferrous Fumarate / Norethindrone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
52
NDC products indexed
130
Distinct labelers/manufacturers represented
27
Linked representative label ⓘ
Teva Women's Health, Inc.
Linked label effective
Feb 20, 2025
Composite sections available
18
Linked SPL Set ID
f29ebcb5-7e65-4092-bfaa-f5ec026fc255
Linked SPL Document ID
21f0dbf2-f0a8-447a-a975-482b4194b1eb
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Teva Women's Health, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →