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: detection of N-Nitrosodimethylamine (NDMA) impurity above...

Name: 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 bottles, Rx only, Pkg By: PD-Rx Pharmaceuti
Brand: PD-Rx Pharmaceuticals, Inc.

Date: October 6, 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 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Quantity: 1683 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 to 16 states: AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NY, NC, OK, OR, WI

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