Recalls / Class II
Class IID-0192-2025
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
- Brand name
- Metformin Er 500 Mg
- Generic name
- Metformin Er 500 Mg
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 82009-117, 82009-118
- FDA application
- ANDA209313
- Affected lot / code info
- Lot #: 4911311A, Exp. Date: 11/2025
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.
Recalling firm
- Firm
- Granules Pharmaceuticals Inc.
- Manufacturer
- Quallent Pharmaceuticals Health LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3701 Concorde Pkwy, Chantilly, Virginia 20151-1126
Distribution
- Quantity
- 6,804 bottles
- Distribution pattern
- Distributor in OH.
Timeline
- Recall initiated
- 2024-12-30
- FDA classified
- 2025-01-08
- Posted by FDA
- 2025-01-15
- Terminated
- 2026-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0192-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.