Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.
What this means for you
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: This is an FDA Class II recall without any reported illnesses or injuries. The hazard is a manufacturing impurity (nitrosamine) detected above interim limits, which represents a precautionary recall due to process deviations rather than immediate confirmed harm.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules USP, 30 mg (distributed nationwide) because testing identified a nitrosamine drug substance related impurity present above the proposed interim limit. The recalled product includes 90-count bottles (NDC# 51991-747-90) and 1000-count bottles (NDC 51991-747-10) manufactured by Towa Pharmaceutical Europe, S.L. Three specific lot numbers are affected: #230201C, #230471C, and #230288C, all with expiration date 01/2026.
This is a Class II recall by the FDA. Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Consumers with affected product should contact their pharmacist or healthcare provider for guidance on alternatives or next steps. More information is available from FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls or by contacting Breckenridge Pharmaceutical, Inc.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Oral Prescription
- Hazard
- nitrosamine-impurity
- manufacturing-deviation
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 (4)
- Lot # 230201C
- exp. date 01/2026 230471C
- exp. date 01/2026 230288C
- exp. date 01/2026
Distribution
Distributed nationwide across the United States.
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