FDA recall, , Moderate risk
Biocon Prazosin Hydrochloride Capsules
Prazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.
Summary by Recall Canary from the FDA notice
What happened
Appco Pharma LLC of Piscataway, New Jersey, recalled Prazosin Hydrochloride Capsules, USP, in 1mg, 2mg, and 5mg strengths, distributed nationwide. The FDA stated the recall was due to a cGMP deviation involving detection of Nitrosamine Drug Substance-Related Impurities, specifically N-nitroso-prazosin impurity C (NNP), above acceptable limits. The recall began on March 27, 2026, and was added to the FDA's Enforcement Report on March 31, 2026.
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Prazosin Hydrochloride Capsules, USP
- Strength
- 2 mg
- NDC
- 70377-067-11
- Lot code
- 2404153UC
- 2404154UC
- 2502055UC
- 2505173UC
- 2505175UC
- Strength
- 1 mg
- NDC
- 70377-066-11
- Lot code
- 2404160C
- 2406253C
- 2407311C
- 2407312C
- 2408350C
- 2505172C
- 2506191C
- Strength
- 5 mg
- NDC
- 70377-068-11
- Lot code
- 2406255UC
- 2406256UC
- 2407313UC
- 2408351UC
- 2408352UC
- 2509311UC
Recall details
- Company began the recall
- Sold in
U.S.A. Nationwide
- Company
- Appco Pharma LLCPiscataway, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98658
- Recall numbers
- D-0419-2026 to D-0421-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
