Duloxetine Delayed-Release Capsules USP recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain…
Why was Duloxetine Delayed-Release Capsules USP 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: 241069C, Exp 05/31/2027
- Product
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain…
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Quantity
- 165,761 90-count bottles
- Distribution
- Nationwide in the USA
- Recall date
- May 13, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)