Granules Recalls Metformin Due to NDMA Impurity
Granules Pharmaceuticals recalls specific lots of Metformin Hydrochloride Extended-Release Tablets due to N-Nitrosodimethylamine (NDMA) impurity levels exceeding FDA limits.
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
Granules Pharmaceuticals Inc. is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because FDA analysis detected an impurity called N-Nitrosodimethylamine (NDMA) above the acceptable intake level. This recall affects both 100 ct. and 500 ct. bottles distributed nationwide in the United States. The record does not specify a remedy or action for consumers at this time. Read more at govinfonow.com/recall/36960-granules-recalls-metformin-due-to-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/36960-granules-recalls-metformin-due-to-ndma-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-1386-2020
Cite this page
“Granules Recalls Metformin Due to NDMA Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36960-granules-recalls-metformin-due-to-ndma-impurity. Based on FDA recall #D-1386-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1386-2020%22&limit=1).
Why it’s dangerous
The recalled tablets contain N-Nitrosodimethylamine (NDMA), an impurity found above the acceptable intake level set by regulatory standards. While the record does not detail specific health outcomes, NDMA is a substance of concern when present in medication beyond safe limits.
Who’s affected
Patients in the United States who have been prescribed Metformin Hydrochloride Extended-Release Tablets, 750 mg, manufactured by Granules India Limited and sold under the Granules Pharmaceuticals brand. Individuals possessing specific lot numbers listed in the record are directly affected.
How to tell if you have this one
Check your bottle for the National Drug Code (NDC) 70010-492-01 (100 ct.) or NDC 70010-492-05 (500 ct.). Verify the lot number and expiration date against the following list: 4920003A/May-21, 4920004A/Jun-21, 4920005A/Jun-21, 4920009A/Nov-21, 4920010A/May-22, 4920011A/Jun-22, 4920012A/Jun-22, 4920013A/Jul-22, 4920014A/Jul-22, 4920015A/Aug-22, 4920016A/Jan-23, or 4920005B/Jun-21.
- Brand
Granules Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Compare the NDC and lot numbers on your Metformin bottle against the recalled list provided in this record.
Consult Your Pharmacist
Contact your pharmacy or healthcare provider to determine if you have one of the affected lots and what steps they recommend.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1386-2020 (July 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1386-2020 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.