BusPIRone Hydrochloride Tablets — Class II drug recall D-1542-2020
Terminated recall by Par Pharmaceutical Inc., reported 2020-09-02, distributed nationwide. Failed Impurity /Degradation Specifications
| Recall number | D-1542-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2020-08-10 |
| Classified | 2020-08-25 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 11,347 bottles |
| Reason classes | specification failure |
| NDC | 49884-0725-01 |
| Lot numbers | 32091002 |
| Expiration dates | 2021-05-20 |
Product
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Reason for recall
Failed Impurity /Degradation Specifications
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-1542-2020. 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.