Teva Pharmaceuticals USA Inc: Drug Recall

Recall #D-1539-2022 · 08/29/2022

Class II: Risk

Recall Details

Recall Number: D-1539-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA Inc
Status: Terminated
Date Initiated: 08/29/2022
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 83,703 bottles

Reason for Recall

Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

Product Description

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.

Distribution Pattern

Nationwide in the US.

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.