Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: DTB23111A, Exp 8/31/2025
- 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, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Product Codes/Lot Numbers:
Lot #: DTB23111A, Exp 8/31/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0277-2025
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