Duloxetine Device Recalls
View recent duloxetine recall notices and find official safety instructions and remedies.
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.medium
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-
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
November 24, 2025
Lot #: 240947C, 240962C, Exp. Date 04/2027medium
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lot #: 240947C, 240962C, Exp. Date 04/2027
November 24, 2025
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026medium
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, I
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
October 9, 2025
3
Active Recalls
0
High Priority
3
Device Types Affected
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