Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity
Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.
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 involving a manufacturing deviation with an identified impurity above the regulatory limit. No hospitalization reports or reported illnesses are stated in the source text, and the hazard is based on exceedance of a known safety threshold rather than confirmed patient harm.
Plain-English summary
Ajanta Pharma USA Inc. is recalling Duloxetine Delayed-Release Capsules, 20 mg (NDC 27241-097-06 and related NDC codes), Lot PA10734, expiring June 2026. The recall affects approximately 117,168 packs distributed nationwide within the United States.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Testing identified the presence of N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm during 12-month and 18-month long-term stability intervals.
Patients taking affected doses of this medication should contact their healthcare provider or pharmacist before stopping use or for guidance on next steps. Healthcare providers and pharmacists should identify and quarantine affected product from dispensing.
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#: PA10734
- Exp. Jun 2026.
UPCs (4)
- 0327241164309
- 0327241099038
- 0327241097065
- 0327241098031
Distribution
Distributed nationwide across the United States.