Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains 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: This is an FDA Class II recall. The source does not report any illnesses or injuries, and the hazard is based on impurity levels detected during stability testing. This qualifies as a moderate-severity precautionary recall involving a manufacturing/formulation deviation.
Plain-English summary
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 30 mg, because the product contains N-nitroso-Duloxetine impurity at levels above the FDA-recommended limit of 0.83 ppm. The impurity was identified during long-term stability testing at 12-month and 18-month intervals. The affected lots include: a) PA10774 (90 Capsules, NDC 27241-098-09, Exp. May 2026); b) PA10794 and PA12174 (30 Capsules, NDC 27241-098-03, Exp. Jun 2026); and c) PA10804 (1000 Capsules, NDC 27241-098-10, Exp. Jun 2026). The product was distributed nationwide within the U.S.
Patients taking this medication should contact their healthcare provider or pharmacist about whether their specific lot is affected and what steps to take. Do not stop taking the medication without medical guidance. Return the recalled product to your pharmacy.
The recalled product
- Product
- DULOXETINE (DULOXETINE)
- Brand
- DULOXETINE
- Manufacturer
- Ajanta Pharma Ltd.
- Hazard
- impurity-above-limit
- 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 (7)
- Lot#: a) PA10774
- Exp. May 2026
- b) PA10794
- PA12174
- Exp. Jun 2026
- c) PA10804
- Exp. Jun-26.
UPCs (4)
- 0327241164309
- 0327241099038
- 0327241097065
- 0327241098031
Distribution
Distributed nationwide across the United States.