Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Metformin Hydrochloride Extended-Release Tablets Recalled by Denton Pharma, Inc. Due to CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Denton Pharma, Inc. directly.
Affected Products
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 30 count (NDC 70934-309-30); b) 60 count (NDC 70934-309-60); c) 90 count (70934-309-90); d) 120 count (NDC 70934-309-98) bottles, Rx Only, Time-Cap Labs Inc. Repackaged by Northwind Pharmaceuticals North Blenheim, NY 12131
Quantity: a) 684; b) 432; c) 3668; d) 2029 bottles
Why Was This Recalled?
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Denton Pharma, Inc.
Denton Pharma, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report