Dextroamphetamine Saccharate — Class III drug recall D-0045-2021
Terminated recall by ANI Pharmaceuticals, Inc., reported 2020-10-28, distributed nationwide. Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
| Recall number | D-0045-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ANI Pharmaceuticals, Inc., Baudette, MN, United States |
| Recall initiated | 2020-10-09 |
| Classified | 2020-10-21 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 13,248 bottles |
| Reason classes | labeling |
| NDC | 43975-0277, 43975-0277-10, 43975-0278, 43975-0278-10, 43975-0279, 43975-0279-10, 43975-0280, 43975-0280-10, 43975-0281, 43975-0281-10, 43975-0282, 43975-0282-10 |
| Lot numbers | 19T14, 20D06 |
| Expiration dates | 2021-12-20, 2022-04-20 |
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of A Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg, 100-count bottle, Rx Only, Mfd. for: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 NDC 43975-279-10
Reason for recall
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
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-0045-2021. 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.