Duloxetine 30 mg capsules recalled for impurity above FDA limits
Direct Rx is recalling Duloxetine D/R 30 mg capsules (also sold as Cymbalta) distributed nationwide because the drug contains N-nitroso-duloxetine impurity above FDA-recommended 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: The FDA classified this as a Class II recall. The source text does not report any illnesses, hospitalizations, or injuries, and the hazard is an impurity above a recommended interim limit rather than a confirmed safety crisis. This fits the Moderate category for a Class II recall without reported adverse health outcomes.
Plain-English summary
Direct Rx is recalling Duloxetine D/R 30 mg capsules packaged and distributed under both the Duloxetine D/R and Cymbalta names. The recall affects 263 bottles distributed nationwide. Specific lot numbers affected are 09JA2530, 31JA2507, 09DE2412, 09JA2528, and 29JA2511, all with expiration date 04/30/2027.
The recall was initiated due to the presence of N-nitroso-duloxetine impurity in the product at levels above the FDA's recommended interim limit. This is a manufacturing deviation identified during quality control procedures.
Consumers who have received this product should consult with their pharmacist or healthcare provider about their specific prescription. Patients should not discontinue their medication without medical guidance.
The recalled product
- Product
- DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
- Manufacturer
- Direct Rx
- Category
- Drug — Antidepressant / SNRI
- Hazard
- impurity-n-nitroso-duloxetine
- cgmp-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 (7)
- Lot: a) 09JA2530
- 31JA2507
- expires: 04/30/2027
- b) Lot: 09DE2412
- 09JA2528
- 29JA2511
- expires: 04/30/2027.
Distribution
Distributed nationwide across the United States.
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