FDA recall, , Moderate risk
Ajanta Pharma Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.
Summary by Recall Canary from the FDA notice
What happened
Ajanta Pharma Ltd. of Aurangabad, India, recalled Duloxetine Delayed-Release Capsules because the presence of N-nitroso-Duloxetine impurity was above the FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
The recall, which began April 29, 2026, and was added to the FDA's Enforcement Report on May 4, 2026, covers products marketed by Ajanta Pharma USA Inc. of Bridgewater, NJ, and distributed nationwide within the U.S. The affected products include 30 mg, 20 mg, and 60 mg capsules in various pack sizes.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
Duloxetine Delayed-Release Capsules
- Strength
- 30 mg
- NDC
- 27241-098-09
- 27241-098-03
- 27241-098-10
- Lot code
- PA10774
- PA10794
- PA12174
- PA10804
- Strength
- 20 mg
- NDC
- 27241-097-06
- Lot code
- PA10734
- Strength
- 60 mg
- NDC
- 27241-099-03
- Lot code
- PA07434
From the FDA notice
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Recall details
- Company began the recall
- Sold in
Nationwide within U.S
- Company
- Ajanta Pharma Ltd.Aurangabad, India
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98785
- Recall numbers
- D-0514-2026 to D-0516-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
