Duloxetine Delayed-Release Capsules recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Why was Duloxetine Delayed-Release Capsules recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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: 241180C, Exp. Date April 2027.
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
- Recalling firm
- Breckenridge Pharmaceutical, Inc.
- Quantity
- 14,729 bottles.
- Distribution
- Nationwide within the United States
- Recall date
- June 17, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)