The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0516-2026·Announced 2026-05-13

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.

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 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.
Category
Drug — Prescription / Antidepressant
Hazard
Affected units
117,168

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.

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 →

Related recalls

Same brand · DULOXETINE

Same manufacturer · Ajanta Pharma Ltd.

See all →

Same hazard · impurity

See all →

Similar recalls