CLASS II Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalled
Granules Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, distributed in Ohio. The recall was initiated on 30 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0192-2025
- FDA event ID
- 96082
- Recalling firm
- Granules Pharmaceuticals, Chantilly, VA
- Brand
- Metformin Er 500 Mg
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2024
- FDA classified
- 8 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Diabetes Medication
Timeline
| 30 Dec 2024 | Recall initiated by company | |
| 8 Jan 2025 | Classified by FDA | +9 days |
| 15 Jan 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
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
Where it was distributed
Distributor in OH.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 4911311A, Exp. Date: 11/2025
Where was it sold?
Distributor in OH.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Metformin recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets 1000mg recalledMetformin Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled | Teva Pharmaceuticals USA | Nitrosamine Impurity | CA |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride | Viona Pharmaceuticals | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Metformin 750 mg Extended Release recalled by RemedyRepack | RemedyRepack | Nitrosamine Impurity | PA |