Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Product description
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Lot numbers, UPCs & expiration codes
Lot #: 17240195, Exp 01/31/2026.
Where it was sold
Nationwide USA and PR
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-0462-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 19, 2025
- FDA report date
- Jun 18, 2025
- Quantity
- 6,759 Con - 90 bottle pack
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0462-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96884
- Address
- 750 Corporate Dr
- Code information
- Lot #: 17240195, Exp 01/31/2026.
- Postal code
- 07430-2009
- Report date
- Jun 18, 2025
- Product type
- Drugs
- Recall number
- D-0462-2025
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 6,759 Con - 90 bottle pack
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
- Distribution pattern
- Nationwide USA and PR
- Recall initiation date
- May 19, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2025