Dextroamphetamine Saccharate — Class II drug recall D-1539-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-09-21, distributed nationwide. Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 10
| Recall number | D-1539-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-08-29 |
| Classified | 2022-09-16 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 83,703 bottles |
| Reason classes | labeling, potency |
| NDC | 00555-0775, 00555-0775-02, 00555-0776, 00555-0776-02, 00555-0777, 00555-0777-02, 00555-0971, 00555-0971-02, 00555-0972, 00555-0972-02, 00555-0973, 00555-0973-02, 00555-0974, 00555-0974-02 |
| Lot numbers | 100023340 |
| Expiration dates | 2024-10 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1539-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.