FDA Drug recall D-0397-2015
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTS…
- FDA Drug
- Class II
- terminated
- Published 2015-03-11
On 2015-03-11 the FDA classified a Class II recall of AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTS… by Qualitest Pharmaceuticals, citing failed tablet specifications: One lot was found to contain oversized tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0397-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-13 |
| Published | 2015-03-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualitest Pharmaceuticals |
| Distribution | US |
Product
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Reason
Failed tablet specifications: One lot was found to contain oversized tablets.
Identifiers
| code_info | Lot T018H14A, Exp 08/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0397-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.