Why it was recalled
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: PA00805, expires: 01/31/2029
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0594-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 27, 2026
- FDA report date
- Jun 24, 2026
- Quantity
- 6,143 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ajanta Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0594-2026, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99046
- Address
- 400 Crossing Blvd Ste 102
- Code information
- Lot: PA00805, expires: 01/31/2029
- Postal code
- 08807-2863
- Report date
- Jun 24, 2026
- Product type
- Drugs
- Recall number
- D-0594-2026
- Classification
- Class II
- Recalling firm
- Ajanta Pharma USA Inc
- 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
- Product description
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- May 27, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2026