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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Prazosin Hydrochloride Capsules Recalled for Excess Impurity Levels

Agency Publication Date: October 24, 2025
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Summary

Teva Pharmaceuticals USA is recalling 580,844 bottles of Prazosin Hydrochloride capsules (1 mg, 2 mg, and 5 mg strengths) due to the presence of an impurity called N-nitroso Prazosin impurity C. Testing revealed that levels of this impurity in specific lots exceed acceptable intake limits set by safety standards. This medication is used to treat high blood pressure, and consumers should check their prescription bottles to see if their medicine is part of the affected batch.

Risk

The recall is due to test results showing levels of a nitrosamine impurity above acceptable safety limits. Nitrosamines are classified as probable human carcinogens, meaning long-term exposure to levels above established limits may increase the risk of developing cancer.

What You Should Do

  1. Check your prescription bottle for Prazosin Hydrochloride 1 mg, 2 mg, or 5 mg capsules distributed by Teva Pharmaceuticals. See the Affected Products section below for the full list of affected codes.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Prazosin Hydrochloride, Capsules, USP, 1 mg
Variants: 1 mg, 100 Capsules, 1000 Capsules
Lot Numbers:
3010544A (Exp 10/2025)
3010545A (Exp 10/2025)
3010567A (Exp 12/2025)
3010590A (Exp 02/2026)
3010601A (Exp 03/2026)
3010602A (Exp 03/2026)
3010603A (Exp 03/2026)
3010652A (Exp 07/2026)
3010670A (Exp 07/2026)
3010671A (Exp 07/2026)
3010678A (Exp 08/2026)
3010700A (Exp 08/2026)
3010701A (Exp 08/2026)
3010440A (Exp 12/2025)
3010672A (Exp 07/2026)
NDC:
0093-4067-01
0093-4067-10

Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Product: Prazosin Hydrochloride, Capsules, USP, 2 mg
Variants: 2 mg, 100 Capsules, 1000 Capsules
Lot Numbers:
3010398A (Exp 12/2025)
3010399A (Exp 12/2025)
3010400A (Exp 12/2025)
3010401A (Exp 12/2025)
3010353A (Exp 12/2025)
3010439A (Exp 01/2026)
3010388A (Exp 01/2026)
3010526A (Exp 03/2026)
3010527A (Exp 03/2026)
3010591A (Exp 07/2026)
3010343A (Exp 10/2025)
3010352A (Exp 11/2025)
3010468A (Exp 02/2026)
3010469A (Exp 02/2026)
3010461A (Exp 02/2026)
3010629A (Exp 09/2026)
3010653A (Exp 01/2027)
3010654A (Exp 02/2027)
3010679A (Exp 02/2027)
3010702A (Exp 02/2027)
3010547A (Exp 04/2026)
3010402A (Exp 02/2028)
3010593A (Exp 07/2026)
3010610A (Exp 09/2026)
NDC:
0093-4068-01
0093-4068-10

Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Product: Prazosin Hydrochloride, Capsules, USP, 5 mg
Variants: 5 mg, 100 Capsules, 250 Capsules, 500 Capsules
Lot Numbers:
3010403A (Exp 02/2026)
3010385A (Exp 02/2026)
3010404A (Exp 02/2026)
3010405A (Exp 03/2026)
3010510A (Exp 03/2026)
3010528A (Exp 03/2026)
3010354A (Exp 03/2026)
3010592A (Exp 08/2026)
3010605A (Exp 08/2026)
3010611A (Exp 08/2026)
3010612A (Exp 08/2026)
3010655A (Exp 02/2027)
3010703A (Exp 02/2027)
3010430A (Exp 11/2025)
3010613A (Exp 08/2026)
3010406A (Exp 02/2026)
NDC:
0093-4069-01
0093-4069-52
0093-4069-05

Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97755
Status: Active
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: Retail Pharmacies
Manufactured In: United States
Units Affected: 3 products (181,659 bottles; 291,512 bottles; 107,673)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.