Prazosin Hydrochloride Capsules — Class II drug recall D-0419-2026
Ongoing recall by Appco Pharma LLC, reported 2026-04-08, distributed nationwide. cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP
| Recall number | D-0419-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Appco Pharma LLC, Piscataway, NJ, United States |
| Recall initiated | 2026-03-27 |
| Classified | 2026-03-31 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 70377-0066, 70377-0066-11, 70377-0067, 70377-0067-11, 70377-0068, 70377-0068-11 |
| Lot numbers | 2026/JUL, 2026/MAR, 2026/MAY, 2027/JUN, 2027/MAY, 2404160C, 2406253C, 2407311C, 2407312C, 2408350C, 2505172C, 2506191C |
Product
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
Reason for recall
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0419-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.