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Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000...

FDA Recall #D-0100-2026 — Class II — October 9, 2025

Recall #D-0100-2026 Date: October 9, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Reason for Recall

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Recalling Firm

Breckenridge Pharmaceutical, Inc. — Berkeley Heights, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

172,263 bottles

Distribution

U.S. Nationwide

Code Information

90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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