Teva Pharmaceuticals USA, Inc: Drug Recall

Recall #D-0321-2024 · 01/25/2024

Class III: Low Risk

Recall Details

Recall Number: D-0321-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA, Inc
Status: Ongoing
Date Initiated: 01/25/2024
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,916 cartons

Reason for Recall

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Product Description

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

Distribution Pattern

nationwide

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.