Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Rising Health Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: March 14, 2025
Share:
Sign in to monitor this recall

Summary

Rising Pharma Holding, Inc. is recalling 1,223 bottles of Duloxetine Delayed-Release Capsules, USP (30 mg), a prescription medication used to treat depression and anxiety. The recall was initiated because testing found the presence of an impurity called N-nitroso-duloxetine at levels higher than the FDA's recommended limit. This recall affects the 1,000-count bottles distributed by Rising Health, LLC.

Risk

N-nitroso-duloxetine is a type of nitrosamine, which are classified as probable human carcinogens that may increase the risk of cancer with long-term exposure above safety limits. No injuries or adverse events have been reported to date regarding this specific product.

What You Should Do

  1. This recall affects Rising Health Duloxetine Delayed-Release Capsules, USP, 30 mg, sold in 1,000-count bottles (NDC 57237-018-99) with lot number DTB23111A and an expiration date of 8/31/2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharma Holding, Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Duloxetine Delayed-Release Capsules, USP (30 mg, 1,000-count bottle)by Rising Health, LLC
Variants: 30 mg, Delayed-Release Capsules
Lot Numbers:
DTB23111A (Exp 8/31/2025)
NDC:
57237-018-99

Rx only product distributed by Rising Health, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96427
Status: Active
Manufacturer: Rising Pharma Holding, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 1223 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.