Preferred Pharmaceuticals recalls Metformin XR tablets with NDMA levels above safe limit
Preferred Pharmaceuticals recalls Metformin HCl Extended Release Tablets (Glucophage XR) due to excessive N-Nitrosodimethylamine (NDMA) detected in some batches. This chemical poses a potential cancer risk. Consumers should check their product details and contact the company for instructions.
Recall notice
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Contact the company
What happened, in plain English
Preferred Pharmaceuticals is recalling Metformin HCl Extended Release Tablets (Glucophage XR) because FDA testing found unsafe levels of N-Nitrosodimethylamine (NDMA). This chemical has been linked to cancer risk in some studies. The recall affects specific batches manufactured by Time-Cap Labs. Read more at govinfonow.com/recall/36692-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above.
Source Summary by GovInfoNow · govinfonow.com/recall/36692-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above · Updated October 4, 2026 · FDA enforcement record: FDA #D-0077-2021
Cite this page
“Preferred Pharmaceuticals recalls Metformin XR tablets with NDMA levels above safe limit.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36692-preferred-pharmaceuticals-recalls-metformin-xr-tablets-with-ndma-levels-above. Based on FDA recall #D-0077-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0077-2021%22&limit=1).
Why it’s dangerous
The recall is for Metformin HCl Extended Release Tablets that contain N-Nitrosodimethylamine (NDMA) levels above the FDA's acceptable limit. This chemical has been associated with potential cancer risk in some studies. The presence of excessive NDMA in these tablets could pose a health hazard over time.
Who’s affected
People who have the specific Metformin HCl Extended Release Tablets (Glucophage XR) with NDC #68788-6932-1 from Time-Cap Labs in Farmingdale, NY are affected. Those with diabetes who take this medication are most at risk.
How to tell if you have this one
Check for the NDC code 68788-6932-1 on the product label. The product was manufactured by Time-Cap Labs in Farmingdale, NY and expires 12/31/2021.
- Brand
Preferred Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 68788-6932-1 on the label to confirm if your product is affected.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “Distributed to two physician's offices located in FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0077-2021 (November 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0077-2021 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.