FDA Class II Recall: DULOXETINE by Ajanta Pharma Ltd.

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 -- and the recall number D-0515-2026. If it matches, stop using or distributing it and contact Ajanta Pharma Ltd. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Ajanta Pharma Ltd. and the affected product is described in FDA's record as: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03. FDA's stated reason for the recall is: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.. The recall is tracked under FDA recall number D-0515-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Ajanta Pharma Ltd.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Ajanta Pharma Ltd.: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03) and recall number D-0515-2026, then follow Ajanta Pharma Ltd.'s recall instructions.

Has Ajanta Pharma Ltd. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Ajanta Pharma Ltd., including 3 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0515-2026.

Related enforcement actions