Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
metFORMIN HCL ER USP 500 mg Recalled by PD-Rx Pharmaceuticals, Inc. Due to CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity...
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 PD-Rx Pharmaceuticals, Inc. directly.
Affected Products
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Quantity: 3703 bottles
Why Was This Recalled?
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Where Was This Sold?
United States
About PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report