Ajanta Pharma recalls

4 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for Ajanta Pharma and put it in plain English.

Recent recalls

  • Ajanta Pharma ranolazine tablets recalled for failed dissolution

    Ajanta Pharma USA Inc. is recalling one lot of Ranolazine Extended-Release Tablets, 1000 mg, because the tablets failed to meet dissolution specifications. This means the medication may not release properly in the body, potentially affecting its effectiveness. The recall affects lot DJ25134 with an expiration date of 11/30/2028, distributed nationwide.

    ModerateFDAOct 7, 2026

  • Ajanta Pharma fluphenazine tablets recalled for impurity level

    Ajanta Pharma USA Inc. is recalling fluphenazine hydrochloride 1mg tablets (NDC 27241-255-01) because stability testing at 18 months found organic impurity levels slightly above specification limits. The tablets contained 1.1% of Impurity-A, exceeding the 1.0% specification. No injuries have been reported.

    ModerateFDASep 16, 2026

  • Ajanta Pharma fenofibrate capsules recalled for CGMP deviations

    Ajanta Pharma USA Inc. is recalling one lot of fenofibrate 200 mg capsules due to manufacturing quality deviations discovered during inspection. The affected lot (PA02216, expiring 12/2029) was distributed nationwide.

    ModerateFDAJul 1, 2026

  • Ajanta aripiprazole tablets recalled for voriconazole mix-up

    Ajanta Pharma USA Inc. distributed bottles labeled as Aripiprazole 30 mg that actually contained Voriconazole 50 mg, a different medication used to treat fungal infections. This mix-up affected 6,143 bottles (Lot PA00805, expiring 01/31/2029) distributed nationwide. The error was discovered and reported to the FDA.

    SeriousFDAJun 24, 2026

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