Product: Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, 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: Failed Moisture Limits: Out of specification for water content
Recall initiated: 20210325
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated