Quick Facts at a Glance
- Recall Date
- May 14, 2026
- Hazard Level
- HIGH
- Brands
- DULOXETINE, Asclemed USA, Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- DULOXETINE, Asclemed USA, Inc.
- Model numbers
- Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
- UPC codes
- 76420-623, 76420-633, 76420-634, 76420-636, 76420-633-20, 76420-633-30, 76420-633-60, 76420-633-90 +6 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 14, 2026
Reported by FDA DRUG
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Asclemed USA Inc. or your healthcare provider for guidance. Notification method: Letter
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Full Description
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.. Generic: DULOXETINE; Brand: DULOXETINE. Reason: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.. Classification: Class II. Quantity: 50 bottles. Distribution: US Nationwide.
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Safety Guide
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