FDA Drug recall D-0163-2017
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distr…
- FDA Drug
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distr… by Ascend Laboratories, citing presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0163-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-02 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ascend Laboratories |
| Distribution | AL, FL, GA, SC, TN |
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
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Identifiers
| ndc | 67877-217-01 |
|---|---|
| ndc | 67877-217-05 |
| ndc | 67877-217-10 |
| ndc | 67877-217-33 |
| ndc | 67877-217-38 |
| ndc | 67877-218-01 |
| ndc | 67877-218-05 |
| ndc | 67877-218-10 |
| ndc | 67877-218-33 |
| ndc | 67877-218-38 |
| ndc | 67877-221-01 |
| ndc | 67877-221-05 |
| ndc | 67877-221-10 |
| ndc | 67877-221-33 |
| ndc | 67877-221-38 |
| ndc | 67877-413-01 |
| ndc | 67877-413-05 |
| ndc | 67877-413-10 |
| ndc | 67877-413-33 |
| ndc | 67877-413-90 |
| ndc | 67877-414-01 |
| ndc | 67877-414-05 |
| ndc | 67877-414-10 |
| ndc | 67877-414-33 |
| ndc | 67877-414-90 |
| code_info | Lot 6121056, exp 5/2019 |
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-0163-2017%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.