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Drug FDA Class II Ongoing cGMP deviation

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

Breckenridge Pharmaceutical, Inc Published Apr 30, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Breckenridge Pharmaceutical, Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Hazards

N-nitroso-duloxetine · primary

Affected products (1)

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

DULOXETINE · 343,344 bottles

NDC: 51991-746, 51991-747, 51991-748, 51991-750, 51991-746-06, 51991-746-90, 51991-746-05, 51991-747-33, 51991-747-90, 51991-747-10, 51991-748-33, 51991-748-90, 51991-748-10, 51991-750-33, 51991-750-90, 51991-750-05, 51991-750-10
Lot codes: 230201C
Code info: Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 14, 2025
  2. Published
    Apr 30, 2025
Recall number
D-0388-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.