Recall: D-0325-2021

Class III - Minor Violations

Class IIIClassification

2021-03-25Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Failed Moisture Limits: Out of specification for water content

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.