Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0836-2026·Announced 2026-09-16

Ajanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure

Ajanta Pharma USA Inc. is recalling Fluphenazine Hydrochloride tablets because testing revealed an organic impurity level slightly above the allowed limit.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The deviation is a minor impurity specification failure (1.1% vs 1.0%) without reported injuries.

Plain-English summary

Ajanta Pharma USA Inc. is recalling Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles. The recall involves 403,200 tablets distributed nationwide within the U.S. The affected lots are DJ23254 (Exp. Date 11/30/2026) and DJ10205 (Exp. Date 04/30/2027).

The recall was initiated because the product failed impurities/degradation specifications during testing at the 18-month long-term stability point. Specifically, the level of Organic Impurity-A measured 1.1 percent, which exceeds the specified limit of 1.0 percent.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product: FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE HYDROCHLORIDE)
Brand: FLUPHENAZINE HYDROCHLORIDE
Manufacturer: Ajanta Pharma USA Inc
Category: Drug — Prescription Drug
Hazard: impurity
Affected units: 403,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lot #: DJ23254
Exp. Date 11/30/2026
DJ10205
Exp. Date 04/30/2027.

UPCs (4)

0327241255014
0327241252013
0327241253010
0327241254017

Distribution

Distributed nationwide across the United States.

Same brand · FLUPHENAZINE HYDROCHLORIDE

Moderate
Fluphenazine Hydrochloride Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2025-04-16
Moderate
Fluphenazine Hydrochloride Tablets 2.5mg Recalled by Glenmark Pharmaceuticals
FDA (Drugs) · 2025-04-16

Same manufacturer · Ajanta Pharma USA Inc

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Same hazard · impurity