Ajanta Pharma Ltd. Recalls

3 recalls found for Ajanta Pharma Ltd. — April 2026.

Medications: 3

The recalls listed below are all active notices associated with Ajanta Pharma Ltd. in the FDA, NHTSA, USDA, and CPSC databases. A recall notice may cover specific lot numbers, model numbers, or production date ranges — check each notice carefully to determine whether your specific product is affected.

If you own a recalled product, stop using it and follow the instructions in the official notice for a refund, replacement, or free repair. Vehicle recall repairs are always free regardless of warranty status. For food and consumer products, most retailers will accept returns even without a receipt.

NoticeMedications

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,

Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

View recall →
NoticeMedications

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0

Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

View recall →
NoticeMedications

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0

Ajanta Pharma Ltd.

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

View recall →