Teva Pharmaceuticals recalls Alprostadil Injection USP 500 mcg/mL vials due to impurities found in stability testing. This medication may cause serious injury if used improperly.
“Teva Alprostadil Injection Recall: Impurities Risk Serious Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34675-teva-alprostadil-injection-recall-impurities-risk-serious-injury. Based on FDA recall #D-0988-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0988-2022%22&limit=1).
Teva Pharmaceuticals USA Inc. recalled Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial due to failed impurity specifications, the FDA said on May 18, 2022. The recall involves 3,109 cartons distributed nationwide.
How to tell if you have it
Brand: Teva
Product: Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only
Carton NDC: 0703-1501-02
Vial NDC: 0703-1501-01
Lot #: 100022404, Exp Date 10/2022
Lot #: 100023333, Exp Dat 12/2022
The hazard
The product failed impurity specifications due to out-of-specification results for impurities obtained during routine stability testing. The FDA classified the recall as Class III.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Teva recalls traZODone 50mg tablets with foreign tablets risk (Aug. 24, 2026), Teva Octreotide Acetate 30mg Kit: Sterility Risk in Injectable Suspension (April 24, 2026), and Teva Recalls Claravis 10mg Due to Impurity Issues (April 6, 2026). Other recent recalls of similar products include Somerset Therapeutics Dexamethasone Injection Recall: Impurities May Cause Harm (Feb. 4, 2026), Sagent Busulfan Injection Recall: Failed Impurities Risk (May 4, 2026), and OneSource Specialty Pharma Methohexital Sodium Recall: Impurities Risk Serious Injury (June 7, 2026).
How to tell if you have this one
Check for vials labeled 'Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton' with NDC 0703-1501-01. The product was distributed by Teva Pharmaceuticals USA, Inc. in specific lots.
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 0703-1501-01 on the vial and lot numbers 100022404 or 100023333.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed nationwide in the US Market” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0988-2022 (May 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0988-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.