Why it was recalled
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Product description
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
Lot numbers, UPCs & expiration codes
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
Where it was sold
Nationwide in the USA
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-0199-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 21, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 11,136 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0199-2026, exactly as published.
Show all FDA fields
- City
- Elmwood Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98036
- Address
- 619 River Dr
- Code information
- Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026
- Postal code
- 07407-1317
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0199-2026
- Classification
- Class III
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 11,136 bottles
- Reason for recall
- Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 21, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2025