HomeNDC LookupDrug shortages › Alteplase Injection

Alteplase Injection shortage

Alteplase 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 19, 2026.

To Be Discontinued ⚠ Supply risk: High Cardiovascular, Hematology, Neurology 1 product 121 days First posted May 21, 2026 Updated May 21, 2026
Here’s the bottom line

Genentech is permanently stopping the 100 mg vial of alteplase injection. The kit form, Activase, is still listed by Genentech as an available source for this medicine.

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 sizes supplied
121
Days in shortage
111
Medicaid Rx (2025)
Source: FDA Drug Shortages Database API (openFDA). Last refreshed Sep 19, 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 Alteplase 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 sizes still supplied
Among manufacturers reporting this shortage
0/1 sizes
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 Alteplase Injection from companies that have not filed an FDA shortage — these are not counted in the figures above. Stock can still vary by pharmacy.
Genentech, Inc.
Plus 1 alternative dosage form of Alteplase.
See all other options & details →
Shortage timeline
  1. May 21, 2026
    Currently in shortage
    1 of 1 product affected.
  2. May 21, 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: Genentech, Inc 📞 800-551-2231 1 NDC click to expand
Status NDC / product Size Availability Related information Reason
To Be Discontinued Activase, Injection, 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE USE (NDC 50242-085-27) NDC 50242-0085-27 Discontinuation of the 100mg vial configuration

These rows are manufacturer reports to the FDA for Alteplase 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 Alteplase Injection? options further down this page.

Why is Alteplase Injection in shortage?

Genentech, the maker of Activase, has reported to the FDA that they are permanently stopping production of one specific version of this medication — the 100 mg vial configuration (the kit containing a single-use 100 mL vial, NDC 50242-085-27). This is what's called a "discontinuation," meaning this particular package and strength will not be coming back from this manufacturer.

It's worth noting that the FDA did not provide a specific public reason for why Genentech made this decision — they simply reported that this configuration is being discontinued. This report covers only this one product from Genentech, so it reflects only their version of alteplase in this specific packaging.

Based on the manufacturer-reported reason(s) and notes on file with the FDA for Alteplase 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 Alteplase Injection?

Alteplase Injection is currently on the FDA drug-shortage list, and I want to walk you through what that means for you.

The affected product is the single-use 100 mL vial (the 100 mg configuration). Right now, this strength has no available source reported. There are no other strengths listed as still supplied on this record.

The reason given is a discontinuation of the 100 mg vial configuration. When a product is marked "to be discontinued," the supply problem may be permanent rather than temporary. Because of that, a conversation with your prescriber or pharmacist is the right next step to plan ahead.

Here is what I suggest, in order:

  1. Do not stop, skip, or change how you use this medicine on your own.
  2. Ask your pharmacy to check with wholesalers and other manufacturers — local stock does not always match national reports.
  3. The same medicine, Activase from Genentech, appears in our records as a same-ingredient option; your pharmacy may be able to source it, though it may not be in local stock.
  4. Since this vial is being discontinued, ask your prescriber or pharmacist about clinician-chosen options that fit your care.

Manufacturer contact numbers are listed on this page for reference; pharmacies usually handle those calls. This is general, national information and may not reflect your local pharmacy's supply.

See “Where else can I get Alteplase 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.

Where else can I get Alteplase 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 Alteplase 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
Activase Kit Genentech, Inc. 50242-0044-13

Alternative dosage forms of Alteplase

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 2 productsclick to expand

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

ProductManufacturerPackageNADAC $/unitAB ratingAvailability
ActivaseNDC 50242-0085-27 Genentech, 1 kit FDA listed
ActivaseNDC 50242-0044-13 Genentech, 1 kit 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 Alteplase Injection — that fall in the same broad treatment class (thrombolytic enzymes) . 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 016922
GCN 47142
HICL code 002803
Ingredient (HICL) Alteplase
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9F
Therapeutic class — specific (HIC3) Thrombolytic Enzymes
AHFS code 20:12.20.00
AHFS class Thrombolytic Agents
FDB label name ACTIVASE 100 MG VIAL
FDB brand name Activase
Legend status F — Federal legend — prescription drug or device
GPI-1485601010002120
GPI classActivase
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.

Alteplase Injection shortage FAQs

Is Alteplase Injection in shortage?
Yes — the FDA currently lists Alteplase Injection in shortage (status: “To Be Discontinued”, first reported May 21, 2026). 1 of 1 product is affected. This is national, manufacturer-reported data, so your pharmacy may still have stock.
Which products are affected?
Activase, Injection, 1 KIT in 1 CARTON (50242-085-27) * 100 mL in 1 VIAL, SINGLE-USE * 100 mL in 1 VIAL, SINGLE USE (NDC 50242-085-27) (NDC 50242-0085-27). The full per-NDC list (availability, manufacturer and status) is in the table above — each NDC links to its own page.
When will Alteplase 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 Alteplase somewhere?
Other manufacturers (Genentech, Inc.) still market it and have not reported a shortage. 1 alternative dosage form of Alteplase is also listed. See “Where else can I get Alteplase Injection?” above — stock still varies by pharmacy.
What should I do if I take Alteplase 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 Alteplase 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.
← Back to all current drug shortages