RecallRadar

FDA Drug recall D-0427-2018

Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North…

On 2018-02-28 the FDA classified a Class III recall of Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North… by Aurobindo Pharma, citing presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0427-2018
ClassificationClass III
Statusterminated
Initiated2018-02-02
Published2018-02-28
Last updated2026-09-13 11:52 UTC
CompanyAurobindo Pharma
DistributionUS

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

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Identifiers

ndc65862-008-50
ndc65862-008-60
ndc65862-008-90
ndc65862-008-01
ndc65862-008-33
ndc65862-008-05
ndc65862-008-99
ndc65862-008-45
ndc65862-009-50
ndc65862-009-60
ndc65862-009-90
ndc65862-009-01
ndc65862-009-33
ndc65862-009-05
ndc65862-009-99
ndc65862-009-44
ndc65862-010-50
ndc65862-010-60
ndc65862-010-90
ndc65862-010-01
ndc65862-010-33
ndc65862-010-05
ndc65862-010-99
ndc65862-010-46
code_infoLot#: MTSC17145-A, Exp. July 2021

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-0427-2018%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.