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  3. Recall Enforcement Event ID: 97755

Recall Enforment Report D-0105-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, Inc, originally initiated on 10-07-2025 for the product Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 The product was recalled due to 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 nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0105-202610-07-202511-05-2025Class II291,512 bottlesPrazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10CGMP 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.Ongoing
D-0104-202610-07-202511-05-2025Class II181,659 bottlesPrazosin 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 0093-4067-10CGMP 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.Ongoing
D-0106-202610-07-202511-05-2025Class II107,673Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05CGMP 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.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0093-4067Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-4068Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-4069Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug