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Breckenridge Pharmaceutical, Inc. Recalls

4 recalls found for Breckenridge Pharmaceutical, Inc.. Check current safety alerts and related brands before using affected products.

Active recalls: 4
Pages: 1

HIGH

FDA DRUG

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,...

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Jun 4, 2026

DULOXETINE

CGMP Deviations:

HIGH

FDA DRUG

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge...

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Jun 4, 2026

DULOXETINE

CGMP Deviations:

HIGH

FDA DRUG

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.,...

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Apr 21, 2026

DULOXETINE

CGMP Deviations;

Health & Personal Care

HIGH

FDA DRUG

Breckenridge Recalls Duloxetine Capsules Over Chemical Hazard

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Nov 24, 2025

DULOXETINE

CGMP Deviations;

Brand Statistics

Total Recalls

4

Pages

1

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