Skip to content
Back to recalls
Drug FDA Class III Ongoing Sub/super-potent

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

Unichem Pharmaceuticals USA Inc. Published May 13, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Unichem Pharmaceuticals USA Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent drug

Hazards

Subpotency · primary

Affected products (1)

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

BUSPIRONE HYDROCHLORIDE · 10,875 Bottles

NDC: 29300-244, 29300-245, 29300-246, 29300-247, 29300-477, 29300-478, 29300-244-01, 29300-244-05, 29300-245-01, 29300-245-05, 29300-246-01, 29300-246-18, 29300-246-05, 29300-246-16, 29300-247-16, 29300-247-01, 29300-247-05, 29300-477-16, 29300-477-01, 29300-477-18, 29300-477-05, 29300-478-16, 29300-478-01, 29300-478-05
Lot codes: ZBUL25001
Code info: Lot: ZBUL25001, Exp 12/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 13, 2026
  2. Published
    May 13, 2026
Recall number
D-0511-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.