Lupin Metformin Tablets Recall: NDMA Impurity Risk
Lupin Pharmaceuticals recalls 500mg extended-release metformin tablets due to NDMA impurity exceeding safe levels. Affected batches manufactured in India with specific batch numbers.
Recall notice
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling 500mg extended-release metformin tablets that contain unsafe levels of NDMA impurity. This impurity could pose health risks to people taking the medication. Read more at govinfonow.com/recall/37053-lupin-metformin-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37053-lupin-metformin-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1334-2020
Cite this page
“Lupin Metformin Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37053-lupin-metformin-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-1334-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1334-2020%22&limit=1).
Why it’s dangerous
The FDA found higher levels of N-Nitrosodimethylamine (NDMA) in these tablets than allowed. NDMA is a potential carcinogen that could increase cancer risk with long-term use.
Who’s affected
People prescribed metformin by a doctor who received this specific batch of tablets are affected. Those with diabetes who take metformin are most at risk.
How to tell if you have this one
Check for the 500mg extended-release metformin tablets with NDC 68180-336-07. The batch number is G901203, and the expiration date is December 2020.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Your Medication
Look for the NDC code 68180-336-07 and batch number G901203 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months 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-1334-2020 (June 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1334-2020 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.