Warning
Teva Pharmaceuticals USA Recalls Prazosin Hydrochloride
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0104-2026Drug / Pharmaceutical
Teva Pharmaceuticals USA Recalls Prazosin Hydrochloride
Teva Pharmaceuticals USA, Inc · Class II — Moderate Risk
Product Description
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
Reason for Recall
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Teva Pharmaceuticals USA, Inc initiated the recall on October 7, 2025 affecting 181,659 bottles. CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. The product was distributed in U.S. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Teva Pharmaceuticals USA, Inc for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination and Teva Pharmaceuticals USA recalls.