FDA DrugsClass II
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma...
Published: June 24, 2026Recall ID: D-0594-2026Category: drugsCountry: US
Reason for Recall / Hazard
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Product Description & Identification
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Nui | N0000175430 |
| Openfda › Upc › 1 | 0327241051036 |
| Openfda › Upc › 2 | 0327241055034 |
| Openfda › Upc › 3 | 0327241053030 |
| Openfda › Upc › 4 | 0327241056031 |
| Openfda › Upc › 5 | 0327241054037 |
| Openfda › Upc › 6 | 0327241052033 |
| Openfda › Unii | 82VFR53I78 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 349490 |
| Openfda › Rxcui › 2 | 349545 |
| Openfda › Rxcui › 3 | 349547 |
| Openfda › Rxcui › 4 | 349553 |
| Openfda › Rxcui › 5 | 402131 |
| Openfda › Rxcui › 6 | 602964 |
| Openfda › Spl id | 2a724a23-cf45-4d22-90f5-ebe68f9b7ab9 |
| Openfda › Brand name | ARIPIPRAZOLE |
| Openfda › Spl set id | d0f910b5-adef-4a93-9369-70f1ed541503 |
| Openfda › Package ndc › 1 | 27241-051-03 |
| Openfda › Package ndc › 2 | 27241-051-08 |
| Openfda › Package ndc › 3 | 27241-052-03 |
| Openfda › Package ndc › 4 | 27241-052-08 |
| Openfda › Package ndc › 5 | 27241-053-03 |
| Openfda › Package ndc › 6 | 27241-053-08 |
| Openfda › Package ndc › 7 | 27241-054-03 |
| Openfda › Package ndc › 8 | 27241-054-08 |
| Openfda › Package ndc › 9 | 27241-055-03 |
| Openfda › Package ndc › 10 | 27241-055-08 |
| Openfda › Package ndc › 11 | 27241-056-03 |
| Openfda › Package ndc › 12 | 27241-056-08 |
| Openfda › Product ndc › 1 | 27241-051 |
| Openfda › Product ndc › 2 | 27241-052 |
| Openfda › Product ndc › 3 | 27241-053 |
| Openfda › Product ndc › 4 | 27241-054 |
| Openfda › Product ndc › 5 | 27241-055 |
| Openfda › Product ndc › 6 | 27241-056 |
| Openfda › Generic name | ARIPIPRAZOLE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | ARIPIPRAZOLE |
| Openfda › Pharm class epc | Atypical Antipsychotic [EPC] |
| Openfda › Manufacturer name | Ajanta Pharma USA Inc. |
| Openfda › Application number | ANDA206174 |
| Openfda › Is original packager | true |
| Event id | 99046 |
| Address 1 | 400 Crossing Blvd Ste 102 |
| Code info | Lot: PA00805, expires: 01/31/2029 |
| Postal code | 08807-2863 |
| Report date | 20260624 |
| Product type | Drugs |
| Product quantity | 6,143 bottles |
| Reason for recall | Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260527 |
| Initial firm notification | Letter |
| Center classification date | 20260616 |
Overview
- Recalling FirmAjanta Pharma USA Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide