Why it was recalled
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Product description
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Lot numbers, UPCs & expiration codes
Lot #: 1023526, 1023555, Expiry: 07/31/2026
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0101-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 16, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- 1,970 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0101-2026, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 97826
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 1023526, 1023555, Expiry: 07/31/2026
- Postal code
- 43217-1188
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0101-2026
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 1,970 cartons
- Reason for recall
- Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 16, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2025