Maalox Total Relief FDA Alerts
The FDA Alerts below may be specifically about Maalox Total Relief or relate to a group or class of drugs which include Maalox Total Relief.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Maalox Total Relief
Voluntary Recall of Certain Family Dollar Over-the-Counter Products
July 21, 2022 -- Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements.
To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.
A list of the recalled products is attached. This recall goes to the retail store level.
Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. This recall does not apply to Delaware, Alaska, Hawaii as no Family Dollar stores in Delaware received any products subject to this recall and Family Dollar does not have any stores in Alaska or Hawaii.
Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- https://www.fda.gov/safety/report-problem-fda
Source: FDA
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The Drug Safety Communication contains additional information for consumers and healthcare professionals, as well as product label photos.
[02/17/2010 - Drug Safety Communication - FDA]
[02/17/2010 - News Release - FDA]
