Class III
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
- Recall number
- D-0836-2026
- Report date
- September 16, 2026
- Classification
- Class III
- Status in dataset
- Ongoing
- Recalling firm
- Ajanta Pharma USA Inc
- Generic names
- FLUPHENAZINE HYDROCHLORIDE
- Brand names
- FLUPHENAZINE HYDROCHLORIDE
- Product NDCs
- 27241-252, 27241-255, 27241-254, 27241-253
Code and lot information
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Distribution
Nationwide within the U.S
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.