Teva Pharmaceuticals USA, Inc: Drug Recall

Recall #D-0439-2024 · 03/28/2024

Class II: Risk

Recall Details

Recall Number: D-0439-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA, Inc
Status: Ongoing
Date Initiated: 03/28/2024
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,304 3x10-cartons

Reason for Recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Product Description

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

Distribution Pattern

Nationwide in the USA

Other Recalls by Teva Pharmaceuticals USA, Inc

Class III: Low Risk 11/07/2025

Defective Container - A defect in the side-seal which allows leakage of product.
Class II: Risk 10/13/2025

Subpotent drug; Clavulanate Potassium component
Class II: Risk 10/07/2025

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.
Class II: Risk 10/07/2025

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.
Class II: Risk 10/07/2025

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.

View all recalls by Teva Pharmaceuticals USA, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.