Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Preferred Pharmaceuticals is recalling 66 bottles of Duloxetine 30mg capsules (Lot J2022G) due to manufacturing deviations that resulted in N-nitroso-duloxetine impurity above FDA limits.
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 that resulted in a nitrosamine impurity exceeding the FDA's interim limit. No illnesses or injuries have been reported, placing it in the 'High' category for risk-of-harm products without reported injury.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Duloxetine Delayed-Release Capsules USP 30mg in 30-count bottles (NDC 68788-9301-03, Lot J2022G, expiring 01/01/2025) due to manufacturing deviations that resulted in the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. A total of 66 bottles were distributed to California, Florida, Oklahoma, Kansas, and Connecticut.
Patients who received this product should contact their pharmacist or doctor immediately to determine if they have received medication from the affected lot and to discuss appropriate next steps.
The recalled product
- Product
- Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Antidepressant
- Hazard
- nitrosamine-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 (2)
- Lot #: J2022G
- Exp: 01/01/2025
Distribution
Distributed in 5 states:
- CA
- CT
- FL
- KS
- OK
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
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27