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.
What this means for you
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
- 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.
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