US Drug Recall Register
Class III · Low risk Terminated Initiated Feb 2, 2018 (9 years ago)

Metformin Hydrochloride Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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.

Recalling firm
Aurobindo Pharma Ltd.
NDC code
65862-010-05
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0427-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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