FDAFDA recall D-0594-2026 · Jun 24, 2026
Ajanta Pharma USA Inc: Aripiprazole Tablets USP recall
Recall found
Product
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.
Reason for recall
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: PA00805, expires: 01/31/2029
- Quantity
- 6,143 bottles
- Distribution
- U.S. Nationwide
- Recalling firm
- Ajanta Pharma USA Inc, Bridgewater, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-27
Source: openFDA enforcement record D-0594-2026 · search recall number D-0594-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.