Amlodipine Besylate USP 10 mg Tablets — Class III drug recall D-0012-2019
Terminated recall by InvaGen Pharmaceuticals, Inc., reported 2018-10-17, distributed nationwide. Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term
| Recall number | D-0012-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InvaGen Pharmaceuticals, Inc., Hauppauge, NY, United States |
| Recall initiated | 2018-10-03 |
| Classified | 2018-10-11 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2021-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,880 bottles |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 00369097128159 |
| NDC | 69097-0126, 69097-0126-05, 69097-0126-15, 69097-0127, 69097-0127-05, 69097-0127-15, 69097-0128, 69097-0128-05, 69097-0128-15 |
| Lot numbers | GG80218 |
| Expiration dates | 2019-12 |
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 for recall
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
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-0012-2019. 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.