Fluphenazine HCl Tablets 1mg
Ajanta Pharma recalls Fluphenazine HCl 1mg tablets (NDC 27241-255-01) due to impurity out-of-specification.
Consult your healthcare provider to obtain a replacement or alternative medication. Continue taking the medication unless your provider advises otherwise, and return the affected product to the pharmacy.
Recall at a glance
- Quantity recalled
- 403,200 tablets
Why it was recalled
Ajanta Pharma USA is recalling Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, because the product failed impurity specifications. Testing at the 18-month long-term stability point found an out-of-specification result for organic impurities (Impurity-A) at 1.1% versus the 1.0% specification limit. Patients should continue taking their medication and consult their healthcare provider for alternatives.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Fluphenazine Hydrochloride Tablets, USP
- Lot code
- DJ23254, 2026
- Strength
- 1 mg
- NDC / UPC
- NDC 27241-255-01
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Ajanta Pharma USA Inc
Editorial summary by Recall Canary · summary updated 2026-09-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification