Buspirone Tablets Recalled for Subpotency
Key Takeaways
- The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class III recall of buspirone hydrochloride tablets, USP, 5 mg, involving 10 875 bottles distributed nationwide and identified as Lot ZBUL25001 (Exp. 12/31/2027).
- The recall was initiated by Unichem Pharmaceuticals (USA), Inc. due to the product being subpotent, a quality issue not expected to cause adverse health consequences.
- Buspirone is an anxiolytic agent indicated for the treatment of anxiety disorders, commonly used in outpatient psychiatric care.
The FDA has classified a Class III recall for buspirone hydrochloride tablets, USP, 5 mg, packaged in 500-count bottles (NDC 29300-244-05). The product was manufactured by Unichem Laboratories Ltd. in India and distributed in the US by Unichem Pharmaceuticals (USA), Inc., based in East Brunswick, NJ. The recall affects 10 875 bottles distributed nationwide, specifically Lot #ZBUL25001, with an expiration date of December 31, 2027. The recall was initiated on April 13, 2026.
The recall was prompted by the product being subpotent, meaning it did not meet labeled strength specifications. The FDA classified the action as Class III on May 1, 2026, indicating that use of the affected product is not likely to cause adverse health consequences, but still represents a deviation from quality standards. Subpotent products may lead to reduced therapeutic effect. The firm notified consignees via letter; no public press release has been issued.
Buspirone is an anxiolytic medication indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety. It is commonly used in outpatient psychiatric and primary care settings. Pharmacists should identify and remove affected Lot #ZBUL25001 from inventory and ensure replacement with unaffected product.
Reference
FDA. Enforcement Report. May 7, 2026. Accessed May 7, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm
