Marksans Pharma Limited recalls Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles,
Marksans Pharma recalls 500mg Metformin extended-release tablets due to NDMA impurity exceeding safe levels. Consumers should stop using affected batches immediately.
Stop using this now
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Contact the company & request your remedy
What happened, in plain English
Marksans Pharma is recalling 50:000 mg Metformin Hydrochloride Extended-Release Tablets because they contain unsafe levels of NDMA. This impurity could pose health risks if taken regularly. Read more at govinfonow.com/recall/37061-marksans-pharma-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37061-marksans-pharma-metformin-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1356-2020
Cite this page
“Marksans Pharma Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37061-marksans-pharma-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1356-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1356-2020%22&limit=1).
Why it’s dangerous
The FDA found higher than safe levels of N-Nitrosodimethylamine (NDMA) in these tablets. NDMA is a potential carcinogen that could increase cancer risk with long-term use.
Who’s affected
People who have the 500 mg extended-release Metformin tablets with NDC 49483-623-01 or XP9004 (expiring Dec 2020) are affected. Those taking this medication for diabetes are most at risk.
How to tell if you have this one
Check for the NDC code 49483-623-01 or batch number XP9004 on the bottle. These tablets were manufactured for Time-Cap Labs, Inc. in Farmingdale, NY and sold in the US.
- Brand
Marksans Pharma- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop taking the recalled Metformin tablets and contact your doctor for alternative treatment options.
Questions people ask
Is this recall affecting all Metformin products?
No, only the specific 500 mg extended-release tablets with NDC 49483-623-01 or batch XP9004 are affected.
How can I check if my tablets are recalled?
Look for the NDC code 49483-623-01 or batch number XP9004 on the bottle label. These tablets were manufactured for Time-Cap Labs, Inc. in Farmingdale, NY.
What should I do if I have the recalled tablets?
Stop using them immediately and contact your doctor for alternative treatment options.
Contact Marksans Pharma
We’ve drafted a message you can send Marksans Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1356-2020 — Marksans Pharma Marksans Pharma Hello, I own a Marksans Pharma that is covered by recall D-1356-2020 from Marksans Pharma. 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-1356-2020 (June 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1356-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.