Appco Pharma recalls 100-count 1mg Prazosin capsules (NDC 70377-066-11) manufactured for Biocon Pharma due to detected nitrosamine impurities above safety limits. Consumers should not use these products.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Appco Pharma is recalling 100-count 1mg Prazosin Hydrochloride capsules (Rx Only) because they contain unsafe levels of nitrosamine impurities. This could pose a health risk if taken as directed.
The capsules contain N-nitroso-prazosin impurities (NNP) above acceptable limits. Nitrosamines are known carcinogens that can increase cancer risk when ingested over time.
People who have received a prescription for these capsules from a healthcare provider. Those with specific medical conditions requiring this medication are at higher risk.
Check for the 100-count 1mg Prazosin Hydrochloride capsules with NDC 70377-066-11. Look for lot numbers 2404160C through 2506191C with expiration dates through 2027.
Identify the product by checking the NDC code 70377-066-11 and lot numbers listed in the recall notice.
The capsules contain N-nitroso-prazosin impurities (NNP) above acceptable limits, which are known carcinogens.
The recall notice does not specify a remedy, so contact your healthcare provider for guidance.
Yes, avoid lot numbers 2404160C through 2506191C with expiration dates through 2027.
We’ve drafted a message you can send Appco Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0419-2026 — Appco Pharma Appco Pharma Hello, I own a Appco Pharma that is covered by recall D-0419-2026 from Appco Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.