Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

metFORMIN HCL ER 500 mg Recalled by PD-Rx Pharmaceuticals, Inc. Due to CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity...

Date: June 5, 2020
Company: PD-Rx Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

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 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127

Quantity: 1969 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