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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 Impurity Presence

Agency Publication Date: October 24, 2025
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Summary

Amerisource Health Services is recalling approximately 7,198 cartons of Prazosin Hydrochloride, a blood pressure medication, because testing found an impurity called N-nitroso Prazosin above acceptable safety limits. The recall affects 1 mg, 2 mg, and 5 mg capsules distributed nationwide under the American Health Packaging brand. Consumers should check their medication against the specific lot numbers and expiration dates to determine if their product is affected.

Risk

The product contains N-nitroso Prazosin impurity C at levels exceeding acceptable intake limits. This impurity is classified as a potential carcinogen, meaning long-term exposure above safety thresholds may increase the risk of developing cancer.

What You Should Do

  1. Check your medication packaging for Prazosin Hydrochloride Capsules in 1 mg (NDC 68084-996-01), 2 mg (NDC 68084-997-01), or 5 mg (NDC 60687-572-32) strengths.
  2. Identify if your product matches the affected lot numbers, which include 1023526, 1023555, 1020109, 1024343, 1025355, 1016996, 1018336, 1021220, 1022421, or 1025017. See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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)by American Health Packaging
Variants: 1 mg, 100 capsules (10x10) cartons
Lot Numbers:
1023526 (Exp 07/31/2026)
1023555 (Exp 07/31/2026)
NDC:
68084-996-01
68084-996-11

Rx only; Distributed by American Health Packaging, Columbus, Ohio

Product: Prazosin Hydrochloride, Capsules, USP (2 mg)by American Health Packaging
Variants: 2 mg, 100 capsules (10x10) cartons
Lot Numbers:
1020109 (Exp 02/28/2026)
1024343 (Exp 09/30/2026)
1025355 (Exp 09/30/2026)
NDC:
68084-997-01
68084-997-11

Rx only; Distributed by American Health Packaging, Columbus, Ohio

Product: Prazosin Hydrochloride, Capsules, USP (5 mg)by American Health Packaging
Variants: 5 mg, 20 capsules (5x4) cartons
Lot Numbers:
1016996 (Exp 11/30/2025)
1018336 (Exp 11/30/2025)
1021220 (Exp 11/30/2025)
1022421 (Exp 08/31/2026)
1025017 (Exp 08/31/2026)
NDC:
60687-572-32
60687-572-33

Rx only; Distributed by American Health Packaging, Columbus, Ohio

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97826
Status: Active
Manufacturer: Amerisource Health Services LLC
Sold By: Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 3 products (1,970 cartons; 1,818 cartons; 3,410 cartons)
Distributed To: Nationwide
Agency Last Updated: October 31, 2025

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.