Direct Rx Metformin HCL E/R Recall: FDA Class II

Why it was recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Product description

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90

Lot numbers, UPCs & expiration codes

Lot: 04DE1902, 11DE1908 Exp. 06/30/2021

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0058-2021
Classification: Class II
Status: Terminated
Recall initiated: Oct 12, 2020
FDA report date: Nov 11, 2020
Quantity: 88 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Direct Rx

Original FDA data

Every field from FDA enforcement report D-0058-2021, exactly as published.

Show all FDA fields

City: Dawsonville
State: GA
Status: Terminated
Country: United States
Event ID: 86601
Address: 94 Worldwide Dr
Code information: Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
Postal code: 30534-6828
Report date: Nov 11, 2020
Product type: Drugs
Recall number: D-0058-2021
Classification: Class II
Recalling firm: Direct Rx
Product quantity: 88 bottles
Termination date: Sep 22, 2021
Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Voluntary / mandated: Voluntary: Firm initiated
Product description: Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Distribution pattern: FL
Recall initiation date: Oct 12, 2020
Initial firm notification: Letter
Center classification date: Nov 2, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0058-2021, published Nov 11, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Direct Rx Metformin HCL E/R 500 mg Recall

Summary