Biocon Pharma Inc. recalled 58,896 bottles of Prazosin Hydrochloride Capsules, USP, 2 mg, 100-count bottle. The product was distributed nationwide in the USA and manufactured by Appco Pharma LLC. 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 their health‑
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 a prescription antihypertensive and symptom-management drug. This recall concerns specific lots produced for Biocon Pharma and distributed nationwide in the United States.
Nitrosamine impurities in drug substances may pose long-term cancer risk. The impurity detected is N-nitroso-prazosin impurity C (NNP) above acceptable limits due to a cGMP deviation.
This recall is not stated as part of a broader industry pattern.
Patients using the recalled lots should stop taking the medication and consult their clinician. The recall affects a limited number of bottles but requires action to avoid potential long-term risk.
FDA recall page for D-0420-2026 and the enforcement report linked there.
No specific refund or replacement timeline is provided in the recall notice.
Keep the bottle, packaging, lot numbers, expiration dates, and all correspondence with the manufacturer or healthcare providers.
Model numbers and lot information below are associated with this recall. NDC 70377-067-11. 58,896 bottles recalled. 100-count bottle. Sold in the USA nationwide. Manufactured for Biocon Pharma Inc., Iselin, NJ. Manufactured by Appco Pharma LLC, Piscataway, NJ.
No injuries or incidents have been reported.
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