FDA recall, , Moderate risk
Ajanta Pharma Aripiprazole Tablets
Aripiprazole Tablets USP are mislabeled, containing Voriconazole Tablets instead.
Summary by Recall Canary from the FDA notice
What happened
Ajanta Pharma USA Inc., of Bridgewater, New Jersey, began a recall on May 27, 2026, of Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, because a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. The product was marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, and made in India. The recall involves 6,143 bottles distributed nationwide in the U.S.
The FDA added the recall to its Enforcement Report on June 15, 2026, and classified it on June 16, 2026. The recall was included in the FDA's weekly enforcement report on June 24, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Aripiprazole Tablets USP
- NDC
- 27241-056-03
- Lot code
- PA00805
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Ajanta Pharma USA IncBridgewater, New Jersey
- Hazard
- Labeling error
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99046
- Recall number
- D-0594-2026
- Quantity recalled
- 6,143 bottles
All recalls from Ajanta Pharma USA Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA · Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
