FDA RECALL: Blood pressure drug pulled over cancer‑linked impurity

More than 175,000 bottles of prazosin recalled after tests detect nitrosamine contamination

National FDA Recall: Appco Pharma LLC has issued a nationwide recall of 175,061 bottles of prazosin hydrochloride capsules, a commonly prescribed blood pressure medication also used off‑label for PTSD‑related nightmares. The recall covers 1 mg, 2 mg, and 5 mg strengths.

The company initiated the recall on March 27, 2026, after testing found N‑nitroso‑prazosin impurity C (NNP) — a nitrosamine considered a probable human carcinogen — at levels above FDA’s acceptable daily intake. The FDA classified the action as a Class II recall on March 31, 2026.

The affected bottles were manufactured by Appco Pharma in New Jersey and distributed for Biocon Pharma, Inc. to pharmacies and wholesalers across the United States. No illnesses or adverse reactions have been reported.

Nitrosamine contamination has triggered multiple drug recalls in recent years, prompting ongoing FDA monitoring across several medication classes.

Recalled Lot Numbers
Prazosin Hydrochloride Capsules — 1 mg
NDC 70377‑066‑11
| Lot Number | Expiration | |———–|————| | 2404160C | March 2026 | | 2406253C | May 2026 | | 2407311C | July 2026 | | 2407312C | July 2026 | | 2408350C | July 2026 | | 2505172C | May 2027 | | 2506191C | June 2027 |

Prazosin Hydrochloride Capsules — 2 mg
NDC 70377‑067‑11
| Lot Number | Expiration | |———–|————| | 2404153UC | March 2026 | | 2404154UC | March 2026 | | 2502055UC | January 2027 | | 2505173UC | May 2027 | | 2505175UC | May 2027 |

Prazosin Hydrochloride Capsules — 5 mg
NDC 70377‑068‑11
| Lot Number | Expiration | |———–|————| | 2406255UC | May 2026 | | 2406256UC | July 2026 | | 2407313UC | July 2026 | | 2408351UC | July 2026 | | 2408352UC | July 2026 | | 2509311UC | September 2027 |

This recall is not optional. If your bottle matches a recalled lot, contact your pharmacist or healthcare provider at once. Do not stop the medication on your own — the risks of abrupt withdrawal can be severe.

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