Duloxetine Delayed-Release Capsules recall (Breckenridge Pharmaceutical, Inc.)
DrugClass IIOngoing
Summary: Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.. Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.
What is being recalled
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Why
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0216-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 24, 2025 |
| Reported | December 10, 2025 |
| Company | Breckenridge Pharmaceutical, Inc. |
| Company location | Berkeley Heights, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7389 bottles |
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