Biocon Pharma Inc. recalled 88,008 bottles of Prazosin Hydrochloride capsules, 1 mg, 100-count bottles, nationwide in the United States. A cGMP deviation detected N-nitroso-prazosin impurity C above acceptable limits. Consumers and healthcare providers should stop using this product immediately and contact Appco Pharma LLC or a healthcare provider for guidance.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Consumers and healthcare providers should stop using this product immediately. Contact Appco Pharma LLC or your healthcare provider for guidance. Notification method: E-Mail
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Prazosin Hydrochloride is an antihypertensive prescription medication used to treat high blood pressure and other conditions. The recalled lots are 1 mg, 100-count capsules distributed nationwide in the United States.
The recall is due to a cGMP deviation that detected N-nitroso-prazosin impurity C above acceptable limits in the drug substance.
This recall is not stated as part of a broader industry pattern.
Patients taking these capsules could be exposed to the impurity. Immediate stop-use is advised, and guidance from a healthcare provider is recommended to discuss alternatives.
Refer to the FDA recall page and the recall email notification from Appco Pharma LLC for official instructions.
Refunds or replacements, if offered, typically take several weeks after the company processes the recall.
Keep the recall notice, email communications, and any correspondence with healthcare providers. Document batch/Lot numbers and dates of purchase.
NDC: 70377-066-11. Product: Prazosin Hydrochloride capsules, USP 1 mg, 100-count bottle (Rx Only). Sold nationwide in the USA. Recall date: 2026-03-27. Quantity: 88,008 bottles. Manufactured for: Biocon Pharma Inc., Iselin, NJ. Manufactured by: Appco Pharma LLC, Piscataway, NJ. Lot numbers and expirations: 2404160C (Exp. 2026-03), 2406253C (Exp. 2026-05), 2407311C (Exp. 2026-07), 2407312C (Exp. 2026-07), 2408350C (Exp. 2026-07), 2505172C (Exp. 2027-05), 2506191C (Exp. 2027-06). Distribution: USA nationwide.
No injuries or incidents have been reported.
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