Duloxetine Delayed-Release Capsules recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles…
Why was Duloxetine Delayed-Release Capsules recalled?
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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 #: 240947C, 240962C, Exp. Date 04/2027
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles…
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Quantity
- 3397 bottles
- Distribution
- Nationwide within the United States
- Recall date
- December 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)