fda_recall · drug_recall · high
Breckenridge Pharmaceutical, Inc. — Class II recall: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. b…
- Event date
- 2026-05-13 00:00:00Z
- Observed
- 2026-07-09 22:51:42Z
- Source ID
- D-0522-2026
- Payload hash
- 74e79033a1af5c44d77aa14c…
Summary
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Status: Ongoing.
Informational only. Not legal, financial, or medical advice.