FDARecall 99733Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was 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.
FDA classification: Class III. Use is not likely to cause adverse health consequences. Status: Ongoing.
Is it yours? Products and codes
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.
- Lot or code
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- FDA recall number
- D-0836-2026
- Quantity
- 403,200 tablets
Distribution (FDA): Nationwide within the U.S
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Ajanta Pharma USA Inc
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.