Direct Rx recalls Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Direct Rx recalls Metformin HCL E/R 500mg tablets due to detected N-Nitrosodimethylamine (NDMA) impurity exceeding safe levels. Consumers should check product details and follow official instructions.
Recall notice
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Contact the company & request your remedy
What happened, in plain English
Direct Rx is recalling Metformin HCL Extended Release 500mg tablets because they contain an unsafe level of NDMA impurity. This impurity could pose health risks if consumed over time, though the exact risk level isn't specified in the recall. Read more at govinfonow.com/recall/36708-direct-rx-metformin-hcl-e-r-500mg-tablets-recall-ndma.
Source Summary by GovInfoNow · govinfonow.com/recall/36708-direct-rx-metformin-hcl-e-r-500mg-tablets-recall-ndma · Updated October 4, 2026 · FDA enforcement record: FDA #D-0058-2021
Cite this page
“Direct Rx Metformin HCL E/R 500mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36708-direct-rx-metformin-hcl-e-r-500mg-tablets-recall-ndma. Based on FDA recall #D-0058-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0058-2021%22&limit=1).
Why it’s dangerous
The recall is for metformin tablets that contain N-Nitrosodimethylamine (NDMA) impurities above the acceptable limit. NDMA is a potential carcinogen that could pose health risks with long-term exposure, though the exact risk level isn't specified in the recall.
Who’s affected
People who purchased Direct Rx Metformin HCL E/R 500mg tablets with NDC 72189-064-90 between specific dates are affected. Those with diabetes who take this medication are most at risk.
How to tell if you have this one
Check for the product name 'Metformin HCL E/R 500 mg, 90 Tabs' with NDC 72189-064-90. The lot numbers 04DE1902 and 11DE1908 were distributed by Direct Rx in Dawsonville, GA.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 72189-064-90 and lot numbers 04DE1902 or 11DE1908 on the packaging.
Questions people ask
Is this product safe to use?
The recall states that the product contains NDMA impurities above acceptable levels, but the official notice does not specify if it's safe to use.
How can I check if I have the recalled product?
Check the NDC code 72189-064-90 and lot numbers 04DE1902 or 11DE1908 on the packaging.
What should I do if I have the recalled product?
The recall does not specify a remedy, so the official notice does not state what action to take.
Contact Direct Rx
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0058-2021 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0058-2021 from Direct Rx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0058-2021 (October 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0058-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.