busPIRone Hydrochloride Tablets — Class III drug recall D-0511-2026
Ongoing recall by Unichem Pharmaceuticals USA Inc., reported 2026-05-13, distributed nationwide. Subpotent drug
| Recall number | D-0511-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unichem Pharmaceuticals USA Inc., East Brunswick, NJ, United States |
| Recall initiated | 2026-04-13 |
| Classified | 2026-05-01 |
| Reported by FDA | 2026-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 10,875 bottles |
| Reason classes | potency |
| NDC | 29300-0244, 29300-0244-01, 29300-0244-05, 29300-0245, 29300-0245-01, 29300-0245-05, 29300-0246, 29300-0246-01, 29300-0246-05, 29300-0246-16, 29300-0246-18, 29300-0247, 29300-0247-01, 29300-0247-05, 29300-0247-16, 29300-0477, 29300-0477-01, 29300-0477-05, 29300-0477-16, 29300-0477-18, 29300-0478, 29300-0478-01, 29300-0478-05, 29300-0478-16 |
| Lot numbers | ZBUL25001 |
| Expiration dates | 2027-12-31 |
Product
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.
Reason for recall
Subpotent drug
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0511-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.