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Benztropine Mesylate Injection shortage

Benztropine Mesylate Injection is currently listed in shortage by the FDA. The FDA lists 1 affected product. This page was last refreshed from FDA data on Sep 25, 2026.

To Be Discontinued ⚠ Supply risk: High Neurology 1 product 241 days First posted Jan 27, 2026 Updated Jan 27, 2026
Here’s the bottom line

Fresenius Kabi is permanently stopping production of benztropine mesylate injection 1 mg/mL. The same medicine at the same strength is still listed as available from other manufacturers.

Don’t stop or change your therapy on your own — talk with your prescriber about the plan that fits you, and ask your pharmacist what’s actually available (see options).

Do you take this drug? See the ‘What to do’ recommendation from Dr. Brian Staiger, PharmD →
1
Affected NDCs
1
Reporting manufacturers
0/1
Reporting mfrs supplying
0/1
Affected strengths supplied
241
Days in shortage
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 25, 2026 · yesterday

What’s in shortage — at a glance

These figures count only the manufacturers that reported this shortage to the FDA — not every company that makes Benztropine Mesylate Injection. Other makers that haven’t reported a problem are shown in the green card below.

Availability of affected NDCs
From the FDA shortage report
1 NDCs
To be discontinued 1
Affected strengths still supplied
Among manufacturers reporting this shortage
0/1 strengths
No supply 1
FDA-reporting manufacturers with supply
Among manufacturers reporting this shortage
0/1 makers
No supply 1
✓ Other manufacturers not reporting a shortage
Still-marketed Benztropine Mesylate Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Hikma Pharmaceuticals USA Inc. Zydus Pharmaceuticals USA Inc.
Plus 7 alternative dosage forms of Benztropine Mesylate.
See all other options & details →
Shortage timeline
  1. Jan 27, 2026
    Currently in shortage
    1 of 1 product affected.
  2. Jan 27, 2026
    First reported to the FDA
    1 product first listed.

Built from FDA posting and update dates. The end date FDA publishes is the posting/update date, not a true resolution date, so durations are approximate.

What exactly is on backorder — by manufacturer

Manufacturer: Fresenius Kabi USA, LLC 📞 888-386-1300 1 NDC click to expand
Status NDC / product Strength Availability Related information Reason
To Be Discontinued Benztropine Mesylate, Injection, 1 mg/1 mL (NDC 63323-970-02) NDC 63323-0970-02 — — Discontinuation of the manufacture of the drug —

These rows are manufacturer reports to the FDA for Benztropine Mesylate Injection — they do not necessarily cover every manufacturer that makes this drug. A company appears here only if it told the FDA it has a supply problem, so other makers may still have stock. That’s the basis for the Where else can I get Benztropine Mesylate Injection? options further down this page.

Why is Benztropine Mesylate Injection in shortage?

Fresenius Kabi USA, LLC has reported to the FDA that they are permanently stopping the manufacture of their benztropine mesylate injection — specifically the 1 mg/1 mL strength and package size. This isn't a temporary hold-up at the factory or a supply bump; it's a full discontinuation of that particular product from this manufacturer.

It's worth knowing that Fresenius Kabi did not share a specific public reason for why they made this decision — just that manufacturing will be discontinued. This report reflects only what this one manufacturer has filed with the FDA, so it speaks only to their version of this product.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Benztropine Mesylate Injection, summarized in plain English by HelloPharmacist. A drug can be short for more than one reason, and the FDA updates these as manufacturers report changes.

What should I do if I take Benztropine Mesylate Injection?

Benztropine mesylate injection is currently on the FDA shortage list, so I want to walk you through what that means for you.

The affected strength is the 1 mg/1 mL injection. Right now, this strength has no available source from the manufacturer that filed this report, Fresenius Kabi. They have noted that they are discontinuing this product, which means this particular supply problem may be permanent rather than temporary.

That said, this report reflects only one manufacturer. The same medicine — benztropine mesylate 1 mg/mL injection — is still listed from other makers, so it has not left the market entirely. Your pharmacy may be able to source it through one of those companies, though it may not be sitting on the local shelf.

Here is what I suggest, in order:

  • Do not stop, skip, or change your dose on your own.
  • Ask your pharmacy to check wholesalers and other manufacturers; the same medicine is also made by Hikma Pharmaceuticals and Zydus Pharmaceuticals.
  • Because the Fresenius Kabi product is being discontinued, talk with your prescriber or pharmacist about your options going forward.

Manufacturer contact numbers are listed on this page for reference, though pharmacies usually handle these calls. This is general, national information and may not match your local pharmacy's actual stock.

See “Where else can I get Benztropine Mesylate Injection?” below ↓ The same medicine from manufacturers not reporting a shortage, alternative dosage forms, and therapeutic equivalents with pricing.
If you are a patient:
  • Don’t stop or change the medication on your own — talk to your prescriber first.
  • If this is part of an ongoing or essential regimen (for example HIV treatment or prevention, seizure, heart, transplant, diabetes or mental-health medicines), do not skip or ration doses — contact your pharmacist or prescriber right away to arrange continued supply before you run out.
  • Ask your pharmacy to check other manufacturers, strengths, package sizes, and nearby stores.
  • Ask your prescriber whether a different strength, formulation, or the brand/generic version is appropriate.
Keep reading
Our full Benztropine guide

Uses, dosing, side effects, prices, and the complete FDA label — written in plain English and pharmacist-reviewed.

Read the Benztropine guide →

Where else can I get Benztropine Mesylate Injection?

FDA shortages are manufacturer-reported — a company only shows up on the shortage list if it told the FDA it has a supply problem, so not every maker of Benztropine Mesylate Injection is necessarily short. Below we pull together the other still-marketed options that are not reported in shortage: the same medicine from manufacturers that haven’t reported a problem, and alternative dosage forms. These may still be out of stock at your pharmacy, and only your prescriber or pharmacist can decide what’s right for you.

Same medicine, other manufacturers (not reported short)

Same active ingredient, dosage form & route as the shortage (matched on the FDB HICL ingredient code), from makers that have not filed a shortage with the FDA:

ProductStrengthForm / routeManufacturerNDC
Benztropine Mesylate BENZTROPINE MESYLATE 1 mg/mL Injection · Intramuscular, Intravenous Hikma Pharmaceuticals USA Inc. 00143-9233-05
Benztropine Mesylate BENZTROPINE MESYLATE 1 mg/mL Injection · Intramuscular, Intravenous Zydus Pharmaceuticals USA Inc. 68382-0860-10

Alternative dosage forms of Benztropine Mesylate

A different form of the same drug (for example a solution when capsules are short). A form change is a clinical decision — ask your prescriber:

Therapeutic equivalents & pricing 5 productsclick to expand

Orange Book–rated equivalents of the affected strengths, with the latest NADAC price (a federal retail-acquisition benchmark, not your copay) and an evidence-based availability label. Cheapest first.

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
Benztropine Mesylate 1 mg/mLNDC 00143-9233-05 Hikma 5 vials — AP FDA listed
Benztropine Mesylate 1 mg/mLNDC 00143-9729-05 Hikma 5 ampules — AP FDA listed
Benztropine Mesylate 1 mg/mLNDC 63323-0970-02 Fresenius 5 vials — AP FDA listed
Benztropine Mesylate 1 mg/mLNDC 68382-0860-10 Zydus 5 vials — AP FDA listed
Benztropine Mesylate 1 mg/mLNDC 68475-0512-02 Navinta 5 vials — AP FDA listed

Equivalents share the same ingredient, strength, dosage form and route; an AB rating means the FDA considers them substitutable. NADAC is a national retail-pharmacy acquisition benchmark from CMS — not what you pay. Availability is inferred from recent pricing, not a stock check.

Other drugs in the same treatment class

These are different medicines — not other versions of Benztropine Mesylate Injection — that fall in the same broad treatment class (antiparkinsonism drugs,anticholinergic) . They are not automatic substitutes: they can differ in how they work, dosing, effectiveness, side effects and what they’re approved to treat. Do not switch on your own. This list is for information only — ask your prescriber or pharmacist whether any of them is appropriate for you.

Identity & classification

GCN Seq No 065420
GCN 27379
HICL code 001905
Ingredient (HICL) Benztropine Mesylate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6B
Therapeutic class — specific (HIC3) Antiparkinsonism Drugs,Anticholinergic
AHFS code 12:08.04.00
AHFS class Antiparkinsonian Agents
FDB label name BENZTROPINE 2 MG/2 ML VIAL
FDB brand name Benztropine Mesylate
Legend status F — Federal legend — prescription drug or device
GPI-1473100010102005
GPI classBenztropine Mesylate
Where does this data come from?
Identity codes come from First Databank (FDB) (HICL ingredient, HIC1–3 therapeutic-class hierarchy, GCN, AHFS class, legend status) and Medi-Span GPI, mapped from a representative affected NDC. Licensed reference data — for identification only.

Other neurology shortages

Benztropine Mesylate Injection shortage FAQs

Is Benztropine Mesylate Injection in shortage?
Yes — the FDA currently lists Benztropine Mesylate Injection in shortage (status: “To Be Discontinued”, first reported Jan 27, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Benztropine Mesylate, Injection, 1 mg/1 mL (NDC 63323-970-02) (NDC 63323-0970-02). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Benztropine Mesylate Injection be available again?
The FDA does not publish a guaranteed restock date, and no estimated-recovery note is on file. Availability can change daily — confirm with your pharmacy.
Can I still get Benztropine Mesylate somewhere?
Other manufacturers (Hikma Pharmaceuticals USA Inc., Zydus Pharmaceuticals USA Inc.) still market it and have not reported a shortage. 7 alternative dosage forms of Benztropine Mesylate are also listed. See “Where else can I get Benztropine Mesylate Injection?” above — stock still varies by pharmacy.
What should I do if I take Benztropine Mesylate Injection?
Don’t stop or change it on your own. Ask your pharmacist whether they can order it from another manufacturer or a different strength/package size, and ask your prescriber about a long-term plan before your supply runs out.

Still have a question about the Benztropine Mesylate Injection shortage?

Ask a pharmacist about this shortage →
How to read the Supply-Risk rating
Low (1–2)Multiple manufacturers still supplying and most strengths or pack sizes sourceable.
Medium (3)Some constraint — fewer suppliers or a notable share of NDCs unavailable.
High (4–5)Down to a single source, most strengths or pack sizes unsourceable, or a long-running outage.
Where does this data come from?
Shortage records come from the FDA Drug Shortages Database API via openFDA (/drug/shortages) — drug, manufacturer & contact, NDC/product, status, availability, reason, therapeutic category and posting/update dates. Current / To Be Discontinued = active; Resolved is kept for history. The Supply-Risk rating is assessed per active ingredient and adds the FDA NDC Directory (still-marketed manufacturers by ingredient & form); same-medicine and equivalent products use First Databank classification + CMS NADAC pricing; Medicaid use + most-affected states come from CMS Medicaid State Drug Utilization Data. Reference only — confirm current status with the manufacturer or FDA before acting on it.
Data structure & sourcing designed and verified by Dr. Brian Staiger, PharmD.
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