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.
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.
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.
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.
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.
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.
Look for the NDC code 82009-117-10 and lot number 4911311A on the bottle.
The product contains a paracetamol tablet that could cause unintended medication effects if taken, so it should not be used.
Check for the NDC code 82009-117-10 and lot number 4911311A on the bottle label.
The official recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send Granules to request your refund or repair — edit it as you like.
Subject: Recall D-0192-2025 — Granules Granules Hello, I own a Granules that is covered by recall D-0192-2025 from Granules. 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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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.
