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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lannett Company, Inc.: Ranitidine Syrup Recalled Due to Presence of NDMA Impurity

Agency Publication Date: November 11, 2019
Share:
Sign in to monitor this recall

Summary

Lannett Company, Inc. is recalling approximately 683,149 bottles of Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL. This prescription medication is used to treat acid reflux and ulcers but was found to contain an impurity called N-Nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen, meaning it could increase the risk of cancer with long-term exposure. Consumers who have this medication should consult their healthcare provider or pharmacist immediately to discuss alternative treatments.

Risk

The product contains NDMA, a substance that is classified as a probable human carcinogen based on laboratory tests. While NDMA can be found in water and foods, the levels detected in these specific batches of medication exceed acceptable safety limits set by health authorities.

What You Should Do

  1. Check your medication label to see if you have Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL with NDC number 54838-550-80.
  2. Identify if your bottle is part of the recall by checking the lot number and expiration date on the packaging against this list: 1503A (10/2019), 1504A (10/2019), 1505A (10/2019), 1523A (10/2019), 1524A (10/2019), 1525A (11/2019), 1561A (12/2019), 1562A (12/2019), 1563A (12/2019), 1589A (12/2019), 1590A (12/2019), 1591A (12/2019), 1614A (01/2020), 1615A (01/2020), 1617A (01/2020), 1644A (02/2020), 1775A (06/2020), 1646A (02/2020), 1647A (02/2020), 1668A (03/2020), 1669A (03/2020), 1670A (03/2020), 1708A (03/2020), 1709A (04/2020), 1710A (04/2020), 1729A (04/2020), 1730A (04/2020), 1731A (04/2020), 1757A (05/2020), 1758A (05/2020), 1759A (05/2020), 1773A (06/2020), 1774A (06/2020), 1989A (12/2020), 1794A (06/2020), 1795A (06/2020), 1796A (06/2020), 1817A (06/2020), 1818A (07/2020), 1819A (07/2020), 1840A (08/2020), 1840B (08/2020), 1841A (08/2020), 1842A (08/2020), 1863A (08/2020), 1864A (09/2020), 1865A (09/2020), 1899A (10/2020), 1900A (10/2020), 1901A (10/2020), 1910A (10/2020), 1911A (10/2020), 1912A (10/2020), 1918A (10/2020), 1919A (10/2020), 1920A (10/2020), 1925A (10/2020), 1926A (10/2020), 1927A (10/2020), 1977A (12/2020), 1978A (12/2020), 1979A (12/2020), 1990A (12/2020), 1991A (12/2020), 1998A (01/2021), 1999A (01/2021), 2000A (01/2021), 2019A (01/2021), 2020A (01/2021), 2065A (03/2021), 2066A (03/2021), 2067A (03/2021), 2071A (03/2021), 2072A (03/2021), 2073A (03/2021), 2076A (03/2021), 2077A (03/2021), 2078A (03/2021), 2126A (05/2021), 2127A (05/2021), 2128A (05/2021), 2164A (06/2021), 2165A (06/2021), 2166A (06/2021), 2179A (06/2021), 2180A (07/2021), 2181A (07/2021), 2214A (08/2021), 2215A (08/2021), 2216A (08/2021).
  3. Immediately contact your doctor or healthcare provider to discuss another treatment option before you stop taking the medication.
  4. Return any unused product from the affected lots to your pharmacy for a refund and contact Lannett Company, Inc. at 1-888-723-3332 for further guidance.
  5. For additional questions or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only
Model:
NDC 54838-550-80
Lot Numbers (90):
1503A
1504A
1505A
1523A
1524A
1525A
1561A
1562A
1563A
1589A
1590A
1591A
1614A
1615A
1617A
1644A
1775A
1646A
1647A
1668A
1669A
1670A
1708A
1709A
1710A
1729A
1730A
1731A
1757A
1758A
1759A
1773A
1774A
1989A
1794A
1795A
1796A
1817A
1818A
1819A
1840A
1840B
1841A
1842A
1863A
1864A
1865A
1899A
1900A
1901A
Date Ranges: 10/2019, 11/2019, 12/2019, 01/2020, 02/2020, 03/2020, 04/2020, 05/2020, 06/2020, 07/2020, 08/2020, 09/2020, 10/2020, 12/2020, 01/2021, 03/2021, 05/2021, 06/2021, 07/2021, 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84149
Status: Resolved
Manufacturer: Lannett Company, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 683,149 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 · 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.