Metformin Hydrochloride Tablets — Class II drug recall D-0163-2017
Terminated recall by Ascend Laboratories LLC, reported 2016-12-07, distributed in AL, FL, GA, SC, TN. Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hy
| Recall number | D-0163-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Montvale, NJ, United States |
| Recall initiated | 2016-11-02 |
| Classified | 2016-11-29 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-06-07 |
| Distributed | AL, FL, GA, SC, TN |
| Quantity | 1,739 bottles |
| NDC | 67877-0217, 67877-0217-01, 67877-0217-05, 67877-0217-10, 67877-0217-33, 67877-0217-38, 67877-0218, 67877-0218-01, 67877-0218-05, 67877-0218-10, 67877-0218-33, 67877-0218-38, 67877-0221, 67877-0221-01, 67877-0221-05, 67877-0221-10, 67877-0221-33, 67877-0221-38, 67877-0413, 67877-0413-01, 67877-0413-05, 67877-0413-10, 67877-0413-33, 67877-0413-90, 67877-0414 and 5 more |
| Lot numbers | 6121056 |
| Expiration dates | 2019-05 |
Product
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Reason for recall
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
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-0163-2017. 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.