Metformin Hydrochloride Tablets — Class III drug recall D-0427-2018
Terminated recall by Aurobindo Pharma Ltd., reported 2018-02-28, distributed nationwide. Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
| Recall number | D-0427-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma Ltd., East Windsor, NJ, United States |
| Recall initiated | 2018-02-02 |
| Classified | 2018-02-16 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2021-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 7,476 bottles |
| NDC | 65862-0008, 65862-0008-01, 65862-0008-05, 65862-0008-33, 65862-0008-45, 65862-0008-50, 65862-0008-60, 65862-0008-90, 65862-0008-99, 65862-0009, 65862-0009-01, 65862-0009-05, 65862-0009-33, 65862-0009-44, 65862-0009-50, 65862-0009-60, 65862-0009-90, 65862-0009-99, 65862-0010, 65862-0010-01, 65862-0010-05, 65862-0010-33, 65862-0010-46, 65862-0010-50, 65862-0010-60 and 2 more |
| Lot numbers | MTSC17145-A |
| Expiration dates | 2021-07-20 |
Product
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Reason for recall
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
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-0427-2018. 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.