FDA recall, , Low risk
Ajanta Pharma Fluphenazine Hydrochloride Tablets
Fluphenazine Hydrochloride Tablets failed impurity specifications during stability testing.
Summary by Recall Canary from the FDA notice
What happened
Ajanta Pharma USA Inc., of Bridgewater, New Jersey, is recalling Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only.
The recall was initiated because the product failed impurities/degradation specifications, with an out-of-specification result for Organic Impurities by HPLC (Impurity-A) of 1.1 percent against a specification of 1.0 percent during testing at the 18 months long term stability. The company began the recall on August 25, 2026, and it was added to the FDA's Enforcement Report on September 8, 2026.
The tablets were distributed nationwide within the U.S. and are marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India. The recall involves 403,200 tablets.
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 your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles
- NDC
- 27241-255-01
- Lot code
- DJ23254
- DJ10205
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- Ajanta Pharma USA IncBridgewater, New Jersey
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99733
- Recall number
- D-0836-2026
- Quantity recalled
- 403,200 tablets
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
