The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0271-2025·Announced 2025-03-19

Duloxetine Capsules Recalled for N-Nitroso Impurity Exceeding FDA Limits

Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II drug recall with a detected high-risk pharmaceutical impurity (N-nitroso-duloxetine) above recommended limits, but with no reported illnesses or injuries. Score follows the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling Duloxetine delayed-release capsules, 20 mg (NDC 51991-746-05), due to the presence of N-nitroso-duloxetine impurity above FDA-recommended interim limits. This impurity was detected as part of a current Good Manufacturing Practice (cGMP) deviation.

The recall encompasses approximately 11,125 bottles with lot number 240098C and an expiration date of January 2027. The affected capsules were manufactured by Towa Pharmaceutical Europe, S.L. in Martorelles, Barcelona, Spain, and distributed nationwide by Breckenridge Pharmaceutical in Berkeley Heights, New Jersey.

Consumers with this specific lot should contact their pharmacy or healthcare provider for guidance regarding this recall.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc.
Category
Drug
Hazard
Affected units
11,125

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 240098C
  • Expiration: 01/2027.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Breckenridge Pharmaceutical, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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