The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0514-2026·Announced 2026-05-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Drug — Prescription Antidepressant
Hazard
Affected units
312,894

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.

Part of a larger recall action

This product is one of 3 recalled by Ajanta Pharma Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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