US Drug Recall Register
Class III · Low risk Terminated Initiated Jan 24, 2020 (7 years ago)

Pioglitazone and Metformin Hydrochloride Tablets

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

Why it was recalled

Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.

What was recalled

Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09

Recalling firm
Macleods Pharma Usa Inc
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0838-2020

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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