Granules Metformin ER Tablets Recall: Paracetamol Contamination Risk
Granules Pharmaceuticals recalls 500mg Metformin ER tablets (1000-count) due to paracetamol contamination. Rx-only product manufactured in India, shipped to US. Consumers should check NDC 82009-117-10 and lot number 4911311A.
Lower-risk recall
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
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What happened, in plain English
Granules Pharmaceuticals recalled 500mg Metformin Hydrochloride Extended-Release Tablets because a paracetamol tablet was found inside the bottle. This contamination could cause unintended medication effects if taken. The product is prescription-only and sold in 1000-count bottles. Read more at govinfonow.com/recall/32340-granules-metformin-er-tablets-recall-paracetamol-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32340-granules-metformin-er-tablets-recall-paracetamol-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0192-2025
Cite this page
“Granules Metformin ER Tablets Recall: Paracetamol Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32340-granules-metformin-er-tablets-recall-paracetamol-contamination-risk. Based on FDA recall #D-0192-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0192-2025%22&limit=1).
Why it’s dangerous
The recall involves a paracetamol tablet (acetaminophen) being found inside a bottle of Metformin ER tablets. This means someone could accidentally take the paracetamol tablet instead of the metformin, potentially causing liver damage or other adverse effects. The product is prescription-only and intended for diabetes treatment.
Who’s affected
Prescription patients who received the specific 500mg Metformin ER tablets from Granules India Limited with NDC 82009-117-10 and lot number 4911311A. People taking metformin for diabetes are most at risk if they accidentally consume the paracetamol tablet.
How to tell if you have this one
Check for the NDC code 82009-117-10 on the bottle label. Look for the lot number 4911311A on the packaging. The product was manufactured in India and shipped to the US by Quallent Pharmaceuticals Health LLC.
- Brand
Granules- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 82009-117-10 and lot number 4911311A on the bottle.
Where it went and when
Where it was distributed
Distributed in Ohio.
FDA distribution: “Distributor in OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 13 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-0192-2025 (December 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0192-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.