The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0515-2026·Announced 2026-05-13

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.

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: 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.
Category
Drug — Prescription Oral Medication
Hazard
Affected units
77,376

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.

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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