Duloxetine 60mg Capsule Recall Due to Manufacturing Impurity
Breckenridge Pharmaceutical recalls 11,100 bottles of Duloxetine 60mg capsules distributed nationwide due to the presence of N-nitroso-duloxetine impurity exceeding FDA recommended interim limits from manufacturing deviations.
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 recall with no reported illnesses or injuries. The product contains an impurity exceeding the FDA's recommended interim limit, constituting a manufacturing defect and potential risk-of-harm product. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules, USP, 60mg (Lot 240301C, expiration 01/2027). The recall affects approximately 11,100 bottles distributed nationwide.
The recall was initiated due to CGMP (Current Good Manufacturing Practices) deviations during manufacturing. The affected product contains N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit.
Patients who have received this medication should consult their healthcare provider or pharmacist regarding the recall. Healthcare providers and patients with questions about this recall should contact Breckenridge Pharmaceutical, Inc., at Berkeley Heights, New Jersey, or the FDA.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Affected units
- 11,100
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#: 240301C
- 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 →Related recalls
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