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Alka-Seltzer Plus Allergy FDA Alerts

The FDA Alerts below may be specifically about Alka-Seltzer Plus Allergy or relate to a group or class of drugs which include Alka-Seltzer Plus Allergy.

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 Alka-Seltzer Plus Allergy

Voluntary Recall of Certain Family Dollar Over-the-Counter Products

Jul 21, 2022 | Audience: Consumers

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.

 

List of Recalled Products

Source: FDA

Drug Safety Communication: Benadryl (diphenhydramine) - Serious Problems with High Doses of the Allergy Medicine

Sep 24, 2020 | Audience: Consumer, Patient, Health Professional, Pharmacy

ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok.

FDA is investigating these reports and conducting a review to determine if additional cases have been reported. FDA will update the public once the review is complete or if there is more information to share.

BACKGROUND: Diphenhydramine is an antihistamine used to temporarily relieve symptoms due to hay fever, upper respiratory allergies, or the common cold, such as runny nose and sneezing.

RECOMMENDATION:

Consumers, parents, and caregivers should store diphenhydramine and all other OTC and prescription medicines up and away and out of children’s reach and sight. FDA recommends you lock up medicines to prevent accidental poisonings by children and misuse by teens, especially when they are home more often due to the COVID-19 pandemic and may be more likely to experiment.

Always read the Drug Facts label included on all OTC medicines to find out if they contain diphenhydramine, how much and how often you should take them, and important safety information. Do not take more than the dose listed on the label, as doing so can cause serious problems. If someone takes too much diphenhydramine and is hallucinating, can’t be awakened, has a seizure, has trouble breathing, or has collapsed, immediately get medical attention or contact poison control at 1-800-222-1222 or online.

Health care professionals should be aware that the “Benadryl Challenge” is occurring among teens and alert their caregivers about it. Encourage teens and caregivers to read and follow the Drug Facts label. In the event of an overdose, health care professionals should attempt to determine whether a patient with a suspected overdose took diphenhydramine.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

[09/24/2020] - Drug Safety Communication - FDA]

Source: FDA

Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

Mar 16, 2018 | Audience: Consumer, Pharmacy

ISSUE: Bayer is voluntarily recalling Alka-Seltzer Plus packages that:

  • Were sold only in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores, Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and Drug) after February 9, 2018.
  • Can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

The affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton.

The ingredients listed on the front sticker of the carton may potentially be different from the ingredients listed on the back of the carton. This may lead consumers to ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their medical condition or they intend to otherwise avoid. There may be potential for serious health consequences.

BACKGROUND: The Alka-Seltzer Plus products subject to the recall are intended to temporarily relieve symptoms associated with cold and flu, such as cough, congestion, fever and/or mucus.

RECOMMENDATION: Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product and contact Bayer with questions, to report any issues experienced or for instructions about how to receive a refund.

Consumers with questions about this recall can contact Bayer Consumer Relations at: 1-800-986-0369 (available Monday - Friday 9:00 AM - 5:00 PM ET). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[03/15/2018 - Press Release - Bayer]