PlainRecalls
FDA Drug Moderate Class II Terminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

Reported: May 19, 2021 Initiated: May 4, 2021 #D-0372-2021

Product Description

Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.

Reason for Recall

Presence of foreign substance: identified as activated carbon.

Details

Units Affected
50868 bottles
Distribution
USA Nationwide
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-142-02.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 50868 bottles.
Why was this product recalled?
Presence of foreign substance: identified as activated carbon.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 19, 2021. Severity: Moderate. Recall number: D-0372-2021.