Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity
Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.
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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is an unknown impurity detected during stability testing, which fits the criteria for a moderate severity recall involving potential quality issues without reported serious injuries.
Plain-English summary
Unichem Pharmaceuticals (USA), Inc. is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets, 30-count bottles. The product is a prescription-only medication manufactured by Unichem Laboratories, Ltd. in India and marketed by Unichem Pharmaceuticals (USA), Inc. in Hasbrouck Heights, New Jersey. The affected product is identified by NDC 29300-126-13.
The recall was initiated because an out-of-specification unknown impurity was observed during 18-month stability testing. The affected lots are GBOL16001 and GBOL16002 with an expiration date of 12/31/2017, and lot GBOL16015 with an expiration date of 03/31/2018. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be discontinued and returned to the pharmacy or supplier for credit. Patients should consult their healthcare provider for alternative treatment options if they have been using this medication.
The recalled product
- Product
- BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
- Brand
- BISOPROLOL FUMARATE
- Manufacturer
- Unichem Pharmaceuticals Usa Inc
- Category
- Drug — Prescription Tablet
- Affected units
- 96,876
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 (5)
- Lot #: GBOL16001
- GBOL16002
- Exp 12/31/2017
- GBOL16015
- Exp 03/31/2018.
UPCs (2)
- 0329300126136
- 0329300127133
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Unichem Pharmaceuticals Usa Inc
See all →- LowBuspirone Hydrochloride Tablets 5 mg Recalled for Subpotency
FDA (Drugs) · 2026-05-13
- ModerateDoxazosin tablets recalled after being imprinted with the wrong identifier
FDA (Drugs) · 2026-02-18
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- CriticalCyclobenzaprine bottles recalled after being filled with meloxicam tablets instead
FDA (Drugs) · 2025-09-24
- ModerateClonidine Hydrochloride 0.3 mg Tablets Recalled for Strength Mix-up
FDA (Drugs) · 2022-09-28
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17