Fluphenazine Hydrochloride Tablet
FDA Recall NDC 27241-252
Latest: Class III · Status: Ongoing · Initiated Aug 25, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fluphenazine Hydrochloride (NDC 27241-252). A significant event, classified as Class III, was initiated on Aug 25, 2026 by Ajanta Pharma Usa Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2026 Class III Recall: Failed impurities/degradation specifications
Recall Number
Class III Ongoing
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.
Aug 25, 2026
Sep 16, 2026
403,200 tablets
Recall Profile & Regulatory Data
Event ID
99733
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Ajanta Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the U.S
Product Description
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.
Batch or Lot Expiration Information
Lot# : DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Affected Packages Involved in this Recall
27241-255-01Fluphenazine Hydrochloride
27241-254-01Fluphenazine Hydrochloride
27241-253-01Fluphenazine Hydrochloride
27241-252-01Fluphenazine Hydrochloride
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
