Duloxetine Delayed-Release Capsules recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC…
Why was Duloxetine Delayed-Release Capsules recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: PA10734, Exp. Jun 2026.
- Product
- Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC…
- Recalling firm
- Ajanta Pharma Ltd.
- Quantity
- 117,168 packs
- Distribution
- Nationwide within U.S
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)