AMLODIPINE BESYLATE TABLETS USP — Class II drug recall D-0397-2015
Terminated recall by Qualitest Pharmaceuticals, reported 2015-03-11, distributed nationwide. Failed tablet specifications: One lot was found to contain oversized tablets.
| Recall number | D-0397-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-02-13 |
| Classified | 2015-03-03 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2016-01-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,808 bottles |
| NDC | 00603-2110-32 |
| Lot numbers | 08/16, T018H14A |
Product
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reason for recall
Failed tablet specifications: One lot was found to contain oversized tablets.
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-0397-2015. 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.