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High risk Drugs & MedicationsClass II

Appco Pharma Prazosin Recall

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: App

Updated March 27, 2026

Appco Pharma has recalled Prazosin Hydrochloride Capsules 2mg due to detection of a potentially harmful impurity (N-nitroso-prazosin) above acceptable limits. This impurity may pose a health risk if taken over time.

Is the Appco Pharma LLC recalled? Yes. This product was recalled by FDA on March 27, 2026. Details below.

What is recalled

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottles, NDC 70377-067-11, manufactured by Appco Pharma LLC (Piscataway, NJ) for Biocon Pharma Inc. (Iselin, NJ). Prescription-only medication.

Am I affected

You're affected if you have a prescription bottle of Prazosin Hydrochloride 2mg, 100-count, with NDC number 70377-067-11. Check the label on your medication bottle for this NDC number.

What to do right now

Do not use this medication. Stop taking it and contact your prescribing doctor or pharmacist right away for guidance on a replacement or alternative treatment. Do not throw away the medication without asking your pharmacist how to safely dispose of it.

The hazard

CGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Brands affected

Appco Pharma LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0420-2026
Classification
Class II
Recalled
March 27, 2026
Read the official notice

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