Duloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg (Lot PA07434, expiration May 2026) because testing found N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.
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: FDA Class II recall with no reported illnesses or hospitalizations. The recall is a precautionary measure based on identification of an impurity above the recommended limit in stability testing, with no actual harm reported.
Plain-English summary
Ajanta Pharma Ltd. is recalling 77,376 packs of Duloxetine Delayed-Release Capsules, 60 mg, marketed nationwide in the United States. The recall was initiated due to current good manufacturing practices (CGMP) deviations: testing at the 12-month and 18-month long-term stability intervals identified the presence of N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm.
The affected product is Duloxetine 60 mg, 30-capsule packs (NDC 27241-099-03), manufactured by Ajanta Pharma Ltd. in India and marketed by Ajanta Pharma USA Inc., Bridgewater, NJ. The specific lot involved is PA07434, with an expiration date of May 2026.
Patients currently taking this medication should consult their healthcare provider before making any changes to their treatment. Consumers who have this product should not use it and should contact their pharmacy or doctor for guidance on obtaining an alternative supply or replacement.
The recalled product
- Product
- DULOXETINE (DULOXETINE)
- Brand
- DULOXETINE
- Manufacturer
- Ajanta Pharma Ltd.
- Hazard
- impurity-n-nitroso-duloxetine
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 (2)
- Lot#: PA07434
- Exp. May 2026.
UPCs (4)
- 0327241164309
- 0327241099038
- 0327241097065
- 0327241098031
Distribution
Distributed nationwide across the United States.