FDA DrugsClass III
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by U...
Published: February 18, 2026Recall ID: D-0306-2026Category: drugsCountry: US
Reason for Recall / Hazard
Tablets/Capsules Imprinted with Wrong ID
Product Description & Identification
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
Additional Source Details
| Field | Value |
|---|---|
| City | East Brunswick |
| State | NJ |
| Openfda › Unii | 86P6PQK0MU |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197625 |
| Openfda › Rxcui › 2 | 197626 |
| Openfda › Rxcui › 3 | 197627 |
| Openfda › Rxcui › 4 | 197628 |
| Openfda › Spl id | e2406e8e-68c2-49dc-9e15-6170f3fffa03 |
| Openfda › Brand name | DOXAZOSIN MESYLATE |
| Openfda › Spl set id | 44bfe5d7-a56a-46f1-8ef3-ad386ab35f0f |
| Openfda › Package ndc › 1 | 29300-351-13 |
| Openfda › Package ndc › 2 | 29300-351-01 |
| Openfda › Package ndc › 3 | 29300-351-10 |
| Openfda › Package ndc › 4 | 29300-352-13 |
| Openfda › Package ndc › 5 | 29300-352-01 |
| Openfda › Package ndc › 6 | 29300-352-10 |
| Openfda › Package ndc › 7 | 29300-353-13 |
| Openfda › Package ndc › 8 | 29300-353-01 |
| Openfda › Package ndc › 9 | 29300-353-10 |
| Openfda › Package ndc › 10 | 29300-354-13 |
| Openfda › Package ndc › 11 | 29300-354-01 |
| Openfda › Package ndc › 12 | 29300-354-10 |
| Openfda › Product ndc › 1 | 29300-351 |
| Openfda › Product ndc › 2 | 29300-352 |
| Openfda › Product ndc › 3 | 29300-353 |
| Openfda › Product ndc › 4 | 29300-354 |
| Openfda › Generic name | DOXAZOSIN MESYLATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DOXAZOSIN MESYLATE |
| Openfda › Manufacturer name | Unichem Pharmaceuticals (USA), Inc. |
| Openfda › Application number | ANDA212329 |
| Openfda › Is original packager | true |
| Event id | 98321 |
| Address 1 | 1 Tower Center Blvd Ste 2200 |
| Address 2 | N/A |
| Code info | Lot # GDSH25006, Exp Date: 08/2027 |
| Postal code | 08816-1145 |
| Report date | 20260218 |
| Product type | Drugs |
| Product quantity | 60,000 tablets |
| Reason for recall | Tablets/Capsules Imprinted with Wrong ID |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260121 |
| Initial firm notification | Letter |
| Center classification date | 20260211 |
Overview
- Recalling FirmUnichem Pharmaceuticals USA Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide