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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 →- ModerateInventia Recalls Chlorthalidone Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-09-23
- ModerateMylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-09
- SevereGolden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
FDA (Drugs) · 2026-09-09
- 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
Similar recalls
- HighTeva metoprolol succinate 100 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
- HighTeva metoprolol succinate 50 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
- ModerateTeva Recalls Risedronate Sodium Tablets Due to Dissolution Failures
FDA (Drugs) · 2017-03-15
- HighTeva metoprolol succinate 200 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
- HighTeva metoprolol succinate 25 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
- LowTeva Recalls Risedronate Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2017-01-25