Duloxetine capsules recalled for nitrosamine impurity above interim safety limit
Breckenridge Pharmaceutical recalls Duloxetine 30 mg delayed-release capsules nationwide due to a manufacturing deviation: nitrosamine impurity above the FDA interim safety limit. Approximately 343,344 bottles affected.
What this means for you
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 classification with no reported illnesses or injuries. The hazard—nitrosamine impurity above interim safety limit—represents a theoretical carcinogenic risk in a risk-of-harm product where injury has not yet been reported, per the rubric.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine (Duloxetine Hydrochloride) delayed-release capsules, 30 mg, due to a current good manufacturing practice (CGMP) deviation. The affected batches contain a nitrosamine-related impurity above the FDA-proposed interim limit for acceptable levels.
The recall affects three lots: 230201C, 230471C, and 230288C (all with expiration date January 2026). Approximately 343,344 bottles have been distributed nationwide. The product is a prescription antidepressant manufactured by Towa Pharmaceutical Europe, S.L. and distributed by Breckenridge Pharmaceutical, Inc. in Berkeley Heights, New Jersey.
Nitrosamines are known to pose a potential carcinogenic risk. Although no illnesses or injuries have been reported to date, the FDA is requiring this recall as a precautionary measure to prevent potential long-term health risks associated with nitrosamine exposure in this medication.
Patients currently taking affected lots should not stop their medication without consulting their healthcare provider. They should check their bottle for the lot number and expiration date. If they have an affected lot, they should contact their pharmacist or healthcare provider about obtaining a replacement from an unaffected batch or alternative treatment.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Antidepressant
- Hazard
- nitrosamine
- manufacturing-defect
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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