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.
Reported: December 10, 2025 Initiated: November 21, 2025 #D-0199-2026
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.
Reason for Recall
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 11,136 bottles
- Distribution
- Nationwide in the USA
- Location
- Elmwood Park, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 11,136 bottles.
Why was this product recalled? ▼
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2025. Severity: Low. Recall number: D-0199-2026.
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