Teva Recalls Zebeta Tablets Due to Failed Dissolution Specifications
Teva Pharmaceuticals is recalling 889 bottles of Zebeta (bisoprolol fumarate) 10mg tablets because they failed dissolution specifications during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential but unreported harm.
Plain-English summary
Teva Pharmaceuticals USA is recalling 889 bottles of Zebeta (bisoprolol fumarate) tablets, 10mg, 30-count bottles. The product is prescription-only and was distributed nationwide. The specific lot number is 34019710A with an expiration date of 5/2017.
The recall was initiated because the product failed dissolution specifications, resulting in an out-of-specification (OOS) result during stability testing. This indicates that the tablets may not dissolve at the required rate, which could affect the delivery of the medication.
Consumers who have this specific lot of Zebeta should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 889
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 34019710A
- Exp 5/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · failed dissolution
See all →- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
- LowSupernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2026-07-29
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- HighLannett niacin extended-release tablets failed dissolution specifications during stability
FDA (Drugs) · 2026-06-10
- HighMajor Pharmaceuticals memantine extended-release capsules fail dissolution specifications
FDA (Drugs) · 2026-04-22