Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Rising Pharma Holding, Inc.
- Reason for Recall:
- CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Product Codes/Lot Numbers:
Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0189-2025
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