Official recall notice
FDA DrugClass IINotable
FDA Recall: Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharm
- Recall date
- 2026-04-08
- Brand
- Appco Pharma LLC
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Recommended action
What to do
88,008 bottles- 100's count
Product description
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.