FDA Drug recall D-0899-2023
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class III
- terminated
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class III recall of Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0899-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-06-27 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Reason
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Identifiers
| ndc | 68180-750-09 |
|---|---|
| ndc | 68180-751-09 |
| ndc | 68180-751-03 |
| ndc | 68180-751-17 |
| ndc | 68180-752-09 |
| ndc | 68180-752-03 |
| ndc | 68180-719-03 |
| ndc | 68180-719-09 |
| ndc | 68180-720-09 |
| ndc | 68180-720-03 |
| ndc | 68180-721-03 |
| ndc | 68180-721-09 |
| ndc | 68180-233-01 |
| ndc | 68180-233-02 |
| ndc | 68180-455-02 |
| ndc | 68180-455-01 |
| code_info | Lot #: A102887, Exp. 6/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0899-2023%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.