Sun Pharmaceutical Industries Inc. is recalling 2,520 bottles of Metformin HCl Extended-Release Tablets, USP (500 mg), a prescription medication used to manage blood sugar levels in adults with type 2 diabetes. The recall was issued because the tablets exceeded the allowed moisture limits, falling out of specification for water content. This voluntary recall affects 500-count bottles distributed nationwide. No injuries or adverse health consequences have been reported to date, and this is considered a low-risk recall. Consumers should speak with their doctor or pharmacist regarding their medication and to arrange for a refund.
The tablets failed to meet the required moisture specifications. Excess water content in extended-release medication can potentially compromise the stability of the drug over time, which could affect its performance or shelf life.
Refund for unused product
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Sources: FDA iRES · Raw API Response
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