Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity Contamination
Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.
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: This is an FDA Class II recall involving a manufacturing defect (CGMP deviation) with a known potential chemical hazard (N-nitroso impurity above interim limit). No illnesses, injuries, or deaths are reported in the source. Per the rubric, when a hazard is theoretical with no reported harm, the maximum score is 3.
Plain-English summary
Amerisource Health Services LLC is recalling 13,678 bottles of Duloxetine Delayed-Release Capsules, USP, 30 mg (Rx only). The capsules are supplied in 90-count bottles and were manufactured by Aurobindo Pharma Limited for BluePoint Laboratories. The affected product lot is DT3023030A with an expiration date of February 28, 2025.
The recall was issued due to a CGMP (Current Good Manufacturing Practice) deviation involving the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
The product was distributed nationwide in the USA.
Consumers with the affected medication should contact their healthcare provider or pharmacist for guidance regarding this recall.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- n-nitroso-impurity
- 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 (1)
- Lot DT3023030A Exp 2/28/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27