FDA-Drug2025-11-05Class II
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Breckenridge Pharmaceutical, Inc.
Hazard
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Sold states
U.S. Nationwide
Affected count
172,263 bottles
Manufactured in
200 Connell Dr Ste 4200, N/A, Berkeley Heights, NJ, United States
Products
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2026Don't want to check this manually?
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