Duloxetine Delayed-Release Capsules USP recall (Breckenridge Pharmaceutical, Inc.)
DrugClass IIOngoing
Summary: Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.. Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.
What is being recalled
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
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 in the USA
How to tell if yours is affected
Lot: 241069C, Exp 05/31/2027
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-0522-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 21, 2026 |
| Reported | May 13, 2026 |
| Company | Breckenridge Pharmaceutical, Inc. |
| Company location | Berkeley Heights, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 165,761 90-count bottles |
More recalls from Breckenridge Pharmaceutical, Inc. · all drug recalls · recalls from April 2026