FDA Drugs recall ·
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only… recall
- Recall number
- D-0836-2026
- Date
- (initiated August 25, 2026)
- Company / brand
- Ajanta Pharma USA Inc
400 Crossing Blvd Ste 102, Bridgewater, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 403,200 tablets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Distribution
Nationwide within the U.S
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0836-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.