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Class II · ModerateActive recall

Prazosin Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 1023526, 1023555, Expiry: 07/31/2026
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmerican Health Packaging
Brand namePRAZOSIN HYDROCHLORIDE
Generic namePRAZOSIN HYDROCHLORIDE
Active ingredient(s)PRAZOSIN HYDROCHLORIDE
Distributed by / forAmerican Health Packaging, Columbus, Ohio 43217, Carton
NDC68084-996-01
Show the full FDA record
Full product labelPrazosin 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
Recalling firmAmerisource Health Services LLC
DistributionNationwide within the United States
Quantity1,970 cartons
Recall initiated2025-10-16
Report date2025-11-05
Recall completed—
Recall numberD-0101-2026
ClassificationClass II
FDA statusOngoing
Origin on fileColumbus OH United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.