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Breckenridge Pharmaceutical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
35
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0582-2026Class IIDuloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: TowJune 4, 2026
D-0583-2026Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 10June 4, 2026
D-0522-2026Class IIDuloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa PharmaceuticaApril 21, 2026
D-0215-2026Class IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: TowNovember 24, 2025
D-0216-2026Class IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: TowNovember 24, 2025
D-0100-2026Class IIDuloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-coOctober 9, 2025
D-0621-2025Class IIDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured byAugust 8, 2025
D-0580-2025Class IIDuloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured byJuly 25, 2025
D-0552-2025Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa PharmaceJuly 15, 2025
D-0511-2025Class IIDuloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa PharmaceuJune 30, 2025
D-0388-2025Class IIDuloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-cApril 14, 2025
D-0387-2025Class IIDuloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa PhApril 14, 2025
D-0308-2025Class IIDuloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured byMarch 26, 2025
D-0269-2025Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa PharmaceuFebruary 28, 2025
D-0270-2025Class IIDuloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa PharmaceuFebruary 28, 2025
D-0271-2025Class IIDuloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa PharmaceutFebruary 28, 2025
D-0161-2025Class IIDuloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. byDecember 6, 2024
D-0162-2025Class IIDuloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. bDecember 6, 2024
D-0009-2025Class IIDuloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa PharmaceutOctober 10, 2024
D-0562-2024Class IIDuloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa PharmaceutiMay 17, 2024