Class III · Lower riskRecall completed
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot# 17212352, Exp 11/31/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGlenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 foreign manufacturer
| Distributed by / for | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 |
| NDC | 68462-879-01 |
Show the full FDA record
| Full product label | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Distribution | Nationwide in the USA |
| Quantity | 480 100-count bottles |
| Recall initiated | 2023-10-20 |
| Report date | 2023-11-08 |
| Recall completed | 2024-08-16 |
| Recall number | D-0085-2024 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Mahwah NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.