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CLASS II · ModerateFDA

Ajanta Pharma USA Inc recalls Aripiprazole Tablets USP

📅 May 27, 2026 · 📍 Nationwide
Recalling company
Ajanta Pharma USA Inc
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
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 27, 2026
Reported
Jun 24, 2026
Distribution
U.S. Nationwide
Status
Ongoing
Quantity
6,143 bottles
Lot / codes
Lot: PA00805, expires: 01/31/2029
Company location
Bridgewater, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0594-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0594-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.