FDA Drug recall D-0012-2019
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla…
- FDA Drug
- Class III
- terminated
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class III recall of Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla… by Invagen Pharmaceuticals, citing subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0012-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-10-03 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Invagen Pharmaceuticals |
| Distribution | US |
Product
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Reason
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Identifiers
| upc | 369097128159 |
|---|---|
| ndc | 69097-126-05 |
| ndc | 69097-126-15 |
| ndc | 69097-127-05 |
| ndc | 69097-127-15 |
| ndc | 69097-128-05 |
| ndc | 69097-128-15 |
| ndc | 3690971281 |
| code_info | Lot #: GG80218, Exp. 12/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0012-2019%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.