FDA DrugsClass III
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactu...
Published: May 13, 2026Recall ID: D-0511-2026Category: drugsCountry: US
Reason for Recall / Hazard
Subpotent drug
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Upc › 1 | 0329300246018 |
| Openfda › Upc › 2 | 0329300245011 |
| Openfda › Upc › 3 | 0329300247015 |
| Openfda › Unii | 207LT9J9OC |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 866018 |
| Openfda › Rxcui › 2 | 866083 |
| Openfda › Rxcui › 3 | 866090 |
| Openfda › Rxcui › 4 | 866094 |
| Openfda › Spl id | ef78a61a-865b-447a-9324-3044e41db506 |
| Openfda › Brand name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Spl set id | a6bdf140-075e-445e-a62d-633a4b97f3a8 |
| Openfda › Package ndc › 1 | 29300-244-01 |
| Openfda › Package ndc › 2 | 29300-244-05 |
| Openfda › Package ndc › 3 | 29300-245-01 |
| Openfda › Package ndc › 4 | 29300-245-05 |
| Openfda › Package ndc › 5 | 29300-246-01 |
| Openfda › Package ndc › 6 | 29300-246-18 |
| Openfda › Package ndc › 7 | 29300-246-05 |
| Openfda › Package ndc › 8 | 29300-246-16 |
| Openfda › Package ndc › 9 | 29300-247-16 |
| Openfda › Package ndc › 10 | 29300-247-01 |
| Openfda › Package ndc › 11 | 29300-247-05 |
| Openfda › Package ndc › 12 | 29300-477-16 |
| Openfda › Package ndc › 13 | 29300-477-01 |
| Openfda › Package ndc › 14 | 29300-477-18 |
| Openfda › Package ndc › 15 | 29300-477-05 |
| Openfda › Package ndc › 16 | 29300-478-16 |
| Openfda › Package ndc › 17 | 29300-478-01 |
| Openfda › Package ndc › 18 | 29300-478-05 |
| Openfda › Product ndc › 1 | 29300-244 |
| Openfda › Product ndc › 2 | 29300-245 |
| Openfda › Product ndc › 3 | 29300-246 |
| Openfda › Product ndc › 4 | 29300-247 |
| Openfda › Product ndc › 5 | 29300-477 |
| Openfda › Product ndc › 6 | 29300-478 |
| Openfda › Generic name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUSPIRONE HYDROCHLORIDE |
| Openfda › Manufacturer name | Unichem Pharmaceuticals (USA), Inc. |
| Openfda › Application number | ANDA210907 |
| Openfda › Is original packager | true |
| Event id | 98728 |
| Address 1 | 1 Tower Center Blvd Ste 2200 |
| Code info | Lot: ZBUL25001, Exp 12/31/2027 |
| Postal code | 08816-1145 |
| Report date | 20260513 |
| Product type | Drugs |
| Product quantity | 10,875 Bottles |
| Reason for recall | Subpotent drug |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260413 |
| Initial firm notification | Letter |
| Center classification date | 20260501 |
Overview
- Recalling FirmUnichem Pharmaceuticals USA Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUSA Nationwide