Metformin Hydrochloride Extended-Release Tablets recall
FDA recall D-0192-2025 · initiated Dec 30, 2024
Granules Pharmaceuticals Inc. recalled Metformin Hydrochloride Extended-Release Tablets in Dec 2024 — an FDA Class II recall (D-0192-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,804 bottles
Details
- Product
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10
- Recalling company
- Granules Pharmaceuticals Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Distributor in OH.
- Initiated
- Dec 30, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Metformin Hydrochloride Extended-Release Tablets recalled?
- Granules Pharmaceuticals Inc. recalled Metformin Hydrochloride Extended-Release Tablets in Dec 2024 — an FDA Class II recall (D-0192-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Metformin Hydrochloride Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0192-2025 was: 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.
- Is a recalled Metformin Hydrochloride Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Metformin Hydrochloride Extended-Release Tablets are affected?
- Distributed: Distributor in OH.. The recall covers these lots — Lot #: 4911311A, Exp. Date: 11/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0192-2025.