Duloxetine delayed-release capsules recalled for N-nitroso impurity contamination
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source indicates an FDA Class II recall with a manufacturing (CGMP) deviation and impurity above recommended limits. The source text does not report any illnesses or injuries, and the hazard is related to manufacturing control rather than an acute safety threat, consistent with a Moderate severity classification.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules USP, 60mg (90-count bottles) due to the presence of N-nitroso-duloxetine impurity above the FDA recommended limit. The product was manufactured by TOWA Pharmaceutical Europe S.L. in Martorelles, Barcelona, Spain, and distributed by Breckenridge Pharmaceutical, Inc. in Berkeley Heights, New Jersey. The recalled lot is 241069C with an expiration date of 05/31/2027.
Approximately 165,761 90-count bottles were distributed nationwide in the USA. This is a Class II recall. Patients taking this medication should consult their healthcare provider before discontinuing use or switching to an alternative treatment. Healthcare providers and patients with questions may contact Breckenridge Pharmaceutical for additional information.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Category
- Drug — Antidepressant / SNRI
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: 241069C
- Exp 05/31/2027
Distribution
Distributed nationwide across the United States.
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