Drug recalls

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made…

Ajanta Pharma USA Inc · Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.…

Class IIIOngoingD-0836-2026
Status
Ongoing
City
Bridgewater
State
NJ
Country
United States
Classification
Class III
Product type
Drugs
Event ID
99733
Recalling firm
Ajanta Pharma USA Inc
Address 1
400 Crossing Blvd Ste 102
Postal code
08807-2863
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S
Recall number
D-0836-2026
Product quantity
403,200 tablets
Recall initiation date
20260825
Center classification date
20260908
Report date
20260916
Code info
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
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.

Reason for recall

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.

Harmonized identifiers (openFDA)
Application number
ANDA217410
Brand name
FLUPHENAZINE HYDROCHLORIDE
Generic name
FLUPHENAZINE HYDROCHLORIDE
Manufacturer name
Ajanta Pharma USA Inc.
Product NDC
27241-252, 27241-255, 27241-254, 27241-253
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
FLUPHENAZINE HYDROCHLORIDE
RxCUI
859841, 860918, 865117, 865123
SPL ID
0069bda4-a743-4edd-a15f-a53cba1a2bff
SPL set ID
47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8
Package NDC
27241-255-01, 27241-254-01, 27241-253-01, 27241-252-01
Is original packager
true
Upc
0327241255014, 0327241252013, 0327241253010, 0327241254017
UNII
ZOU145W1XL
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.