# FDA recall D-0419-2026

> **Appco Pharma LLC** · Class II · drug recall initiated 2026-03-27.

## 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.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0419-2026
- **Recalling firm:** Appco Pharma LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-27
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Piscataway, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0419-2026

## Citation

> AI Analytics. FDA recall D-0419-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0419-2026. Source: US FDA. Licensed CC0.

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