Fluphenazine Hydrochloride Tablets Recalled Due to Failed Impurities Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for fluphenazine hydrochloride tablets, USP, 1 mg. The affected batches have been identified as Lots DJ23254 (expires November 2026) and DJ10205 (expires April 2027), containing 403 200 tablets.
• The recall was initiated by Ajanta Pharma USA, Inc due to the product’s failure to meet impurities specifications, a quality issue that is not likely to cause adverse health consequences.
• Fluphenazine is used to treat schizophrenia.

The FDA has issued a Class III recall for fluphenazine hydrochloride tablets, USP, 1 mg, affecting 403 200 tablets. This product is being recalled by Ajanta Pharma USA, Inc based in Bridgewater, New Jersey. The recall was initiated on August 25, 2026, and received a Class III classification on September 8, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated after the product failed its testing for organic impurities. This deficiency affects Lots DJ23254 and DJ10205, which will expire in November 2026 and April 2027, respectively. Ajanta Pharma USA sent out a public notice via letter; no press release has been issued for this recall.

Fluphenazine is a prescription medication used to treat psychotic disorders such as schizophrenia. Pharmacists should identify and quarantine Lots DJ23254 and DJ10205, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 16, 2026. Accessed September 16, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222370