Appco Pharma recalls 5mg prazosin capsules with nitrosamine impurities that may pose health risks. Affected lots manufactured between 2024-2026.
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Appco Pharma is recalling 5mg prazosin capsules that contain unsafe levels of nitrosamine impurities. This could potentially cause health issues if taken. The recall affects specific production lots with expiration dates through 2026.
The capsules contain N-nitroso-prazosin impurities above acceptable limits. Nitrosamines are known carcinogens that can increase cancer risk. This impurity was detected during manufacturing quality checks.
Prescription patients who have the specific lot numbers listed in the recall. Patients using the medication for hypertension or other conditions may be at risk.
Check your prescription bottle for the lot numbers: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, or 2509311UC. The expiration dates range from May 2026 to September 2027.
Look for the lot numbers listed in the recall: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, or 2509311UC.
The recall states that the product contains unsafe levels of nitrosamine impurities, so it is not safe to use.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
Check your prescription bottle for the lot numbers: 2406255UC, 2406256UC, 2407313UC, 2408351UC, 2408352UC, or 2509311UC.
We’ve drafted a message you can send Appco Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0421-2026 — Appco Pharma Appco Pharma Hello, I own a Appco Pharma that is covered by recall D-0421-2026 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.
