Ajanta Pharma Ltd. 2026-05-13 Health serious FDA
Health · FDA · Recall #FDA-D-0516-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta… Recall
Issued May 13, 2026 · Ajanta Pharma Ltd.
In May 2026, Ajanta Pharma Ltd. recalled the Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ajanta Pharma Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ajanta Pharma Ltd.
- Category
- Health
- Recall date
- May 13, 2026
- Units affected
- Not reported
- Sold at
- Nationwide within U.S
- Recall number
- FDA-D-0516-2026
- Made in
- India
- Issuing agency
- FDA
In context
- Ajanta Pharma Ltd. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.