Time-Cap Labs Recalls Metformin Due to NDMA Impurity
Time-Cap Labs recalls 500 mg Metformin ER tablets due to N-Nitrosodimethylamine (NDMA) impurity above acceptable levels. Check your bottle.
Use caution until it’s fixed
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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What happened, in plain English
Time-Cap Labs, Inc. is recalling bottles of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg because FDA analysis detected an impurity called N-Nitrosodimethylamine (NDMA) above the acceptable intake level. The product was manufactured by Marksans Pharma Limited and distributed nationwide. The recall record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/37061-time-cap-labs-recalls-metformin-due-to-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/37061-time-cap-labs-recalls-metformin-due-to-ndma-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-1356-2020
Cite this page
“Time-Cap Labs Recalls Metformin Due to NDMA Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37061-time-cap-labs-recalls-metformin-due-to-ndma-impurity. 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 medication contains N-Nitrosodimethylamine (NDMA), an impurity found at levels above the acceptable intake limit. While the specific health effects are not detailed in this record, NDMA is a known contaminant that raises safety concerns regarding long-term exposure.
Who’s affected
Individuals who have been prescribed Metformin Hydrochloride Extended-Release Tablets, USP 500 mg by Time-Cap Labs, Inc., specifically those with bottles containing NDC 49483-623-01 and lot number XP9004.
How to tell if you have this one
Look for bottles of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg manufactured by Marksans Pharma Ltd. Check the label for NDC 49483-623-01 and lot number XP9004 with an expiration date of 12/2020.
- Brand
Time-Cap Labs- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.3 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-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 qwen3.6:35b-a3b on October 11, 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.