Duloxetine Recall: Ajanta Pharma USA 60 mg capsules
The recall covers Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, distributed nationwide in the U.S. and marketed by Ajanta Pharma USA Inc. It is being recalled due to CGMP deviations with the presence of N-nitroso-Duloxetine impurity above FDA's 0.83 ppm limit identified at 12-month and 18-month stability intervals. Affected lot PA07434, exp May 2026.
| Brand | Ajanta Pharma Ltd. |
|---|---|
| Product | 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 |
| Reason | 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. |
| Severity | moderate |
| Units affected | 3648 |
| Distribution | Nationwide within U.S |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if your product is from Lot PA07434 (Exp May 2026). If so, stop using it now.
- Do not consume the recalled capsules. Keep them away from children.
- Return or dispose of the product per local instructions or contact the pharmacy for guidance on replacement or refund.
- If you took any of the product or have health concerns, contact your healthcare provider and report adverse events to FDA MedWatch.
How to identify the recalled item
| Lot / date codes | Lot#: PA07434, Exp. May 2026. |
|---|---|
| Lot / date codes | Lot # PA02216; Exp. 12/2029 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other duloxetine recalls
- Duloxetine Recall: Ajanta Pharma USA DR Capsules 30 mg · 2026-07-29
- Duloxetine Recall: Cymbalta 30 mg capsules (30 & 60 caps) · 2026-07-01
- Duloxetine Recall: Breckenridge 3,591 bottles · 2026-06-17
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.