Aripiprazole Tablets USP recall
FDA recall D-0594-2026 · initiated May 27, 2026
Ajanta Pharma USA Inc recalled Aripiprazole Tablets USP in May 2026 — an FDA Class II recall (D-0594-2026) because Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,143 bottles
Details
- 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.
- Recalling company
- Ajanta Pharma Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- May 27, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was Aripiprazole Tablets USP recalled?
- Ajanta Pharma USA Inc recalled Aripiprazole Tablets USP in May 2026 — an FDA Class II recall (D-0594-2026) because Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Aripiprazole Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0594-2026 was: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
- Is a recalled Aripiprazole Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Aripiprazole Tablets USP are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot: PA00805, expires: 01/31/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0594-2026.