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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 4911311A, Exp. Date: 11/2025
Where it was sold
Distributor in OH.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0192-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 30, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 6,804 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0192-2025, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 96082
- Address
- 3701 Concorde Pkwy
- Code information
- Lot #: 4911311A, Exp. Date: 11/2025
- Postal code
- 20151-1126
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0192-2025
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product quantity
- 6,804 bottles
- Termination date
- Jan 15, 2026
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributor in OH.
- Recall initiation date
- Dec 30, 2024
- Initial firm notification
- Center classification date
- Jan 8, 2025