Preferred Pharmaceuticals recalls Metformin XR tablets due to NDMA impurity exceeding safe limits. This may pose health risks with long-term use. Affected lots include C2520W through G2720A.
“Preferred Pharmaceuticals Metformin XR Recall: NDMA Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36174-preferred-pharmaceuticals-metformin-xr-recall-ndma-impurity-risk. Based on FDA recall #D-0385-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2021%22&limit=1).
The FDA announced on April 28, 2021, that Preferred Pharmaceuticals, Inc. voluntarily recalled its Metformin HCl Extended Release Tablets USP 500 mg due to the presence of NDMA impurity exceeding acceptable limits. The agency classified this Class II recall as ongoing.
According to the FDA, the product contains N-Nitrosodimethylamine (NDMA) impurity that exceeds the Acceptable Daily Intake Limit of 96ng/day. The recall is classified as Class II.
Context
GovInfoNow's records show Preferred Pharmaceuticals, Inc. has had 32 other recalls on record since August 15, 2018. Other recent recalls of similar products include Preferred Pharma Recalls Lidocaine Ointment Due to Content Issues (September 28, 2026), Geri-Care Eye Drops Recalled for Sterility Risk (March 25, 2026), and Preferred Pharma Recalls Ondansetron ODT Due to Defective Seals (November 17, 2025). Other recent recalls of similar products include Amneal traMADol 50mg Tablets Recall: NDSRI Impurity Risk (March 19, 2026), Zydus Mirabegron 25mg Tablets Recall: N-Nitroso Impurity Risk (August 5, 2026), and Zydus Clomipramine Capsules Recall: Nitrosamine Impurities Risk (October 22, 2025).
How to tell if you have this one
Check for the product name 'Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR' on the label. Look for lot codes C2520W, E0620F, G2020M, or G2720A with expiration dates up to April 30, 2022.
Brand
Preferred Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot code and expiration date on the packaging to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “Distributed to two physician consignees located in FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA published this recall 28 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0385-2021 (April 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0385-2021 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.