Buspirone Hydrochloride Tablets 5 mg Recalled for Subpotency
Unichem Pharmaceuticals USA Inc. is recalling Buspirone Hydrochloride Tablets, USP, 5 mg because the drug is subpotent. The recall affects approximately 10,875 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as Class III, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Unichem Pharmaceuticals USA Inc. is voluntarily recalling Buspirone Hydrochloride Tablets, USP, 5 mg due to subpotency. The recalled product is a 500-count bottle with NDC 29300-244-05, Lot ZBUL25001, expiration date 12/31/2027. Approximately 10,875 bottles have been distributed nationwide.
The product was manufactured by Unichem Laboratories Ltd. in India and distributed for Unichem Pharmaceuticals (USA), Inc., located in East Brunswick, New Jersey. This is a Class III recall initiated by the firm on April 13, 2026.
Patients currently taking the affected medication should not stop taking their medication without consulting their healthcare provider. Consumers with questions should contact Unichem Pharmaceuticals (USA), Inc. at 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816-1145.
The recalled product
- Product
- BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
- Brand
- BUSPIRONE HYDROCHLORIDE
- Manufacturer
- Unichem Pharmaceuticals USA Inc.
- Category
- Drug — Prescription Oral Tablet
- Hazard
- Affected units
- 10,875
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: ZBUL25001
- Exp 12/31/2027
UPCs (3)
- 0329300246018
- 0329300245011
- 0329300247015
Distribution
Distributed nationwide across the United States.
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