Bayer’s Alka-Seltzer Plus Recall: What Consumers Need to Know
Clear steps to verify mislabeled cold and flu meds and claim a refund with confidence.
Bayer’s Alka-Seltzer Plus Recall: Comprehensive Consumer Guide
In early 2018, Bayer, one of the most recognized names in over-the-counter medicine, announced a voluntary recall of several Alka-Seltzer Plus cold and flu products. The recall stems from a critical labeling error that may put consumers at risk for potentially severe allergic or adverse reactions. This guide explores the details of the recall, its implications for consumers, and the steps you should take if you own one of the affected products.
Table of Contents
- Overview of the Recall
- Causes and Discovery
- Potential Health Risks
- How to Identify Recalled Alka-Seltzer Plus Packages
- Affected Product Details
- Actions by Bayer and Retailers
- Consumer Steps and Refund Process
- FDA and Regulatory Involvement
- History of Alka-Seltzer Plus Recalls
- Frequently Asked Questions
- Additional Resources
Overview of the Recall
Bayer Consumer Care initiated a voluntary recall of certain Alka-Seltzer Plus cold and flu remedies after discovering mislabeling issues. The ingredients listed on the front sticker of some packages could differ from those actually inside the carton—a problem that could lead to serious health outcomes, such as allergic or anaphylactic reactions, or unintended ingestion of contraindicated substances.
- The recall applies only to select lots sold in U.S. retail outlets.
- It specifically affects Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels and certain other Alka-Seltzer Plus varieties packaged after February 9, 2018.
- Retailers impacted include Walmart, CVS, Walgreens, Kroger, and several of their associated outlets.
Causes and Discovery of the Recall
Bayer discovered the labeling issue during internal quality control reviews. Packages affected had a mismatched or reversed label on the blister foil card, or mismatched ingredient lists between the carton’s front and back.
- Less than 4% of packages in the specified lot were affected, though all individual capsules were properly imprinted.
- This problem was reported before customers had filed complaints of adverse reactions, highlighting Bayer’s proactive efforts.
Potential Health Risks Associated with Mislabeling
The main concern is that consumers may ingest ingredients to which they are allergic or which do not align with their health conditions. Some potential risks include:
- Allergic Reactions: Consuming products with undisclosed allergens can trigger mild to severe responses, from rashes to life-threatening anaphylaxis.
- Contraindications: Individuals with certain medical conditions could experience negative reactions if the product contains substances meant to be avoided.
- Drug Interactions: Those taking other medications might be unaware of potential harmful interactions if ingredient information is inaccurate.
What others are reading
According to the FDA and Bayer, to date, no complaints leading to adverse health consequences have been reported for this recall. However, the possibility for such events led to the swift recall action.
How to Identify Recalled Alka-Seltzer Plus Packages
To help consumers identify whether their cold and flu medication is part of the recall, Bayer and the FDA issued the following instructions:
- Look for the Bayer logo on the lower left corner of the front of the carton.
- If the background behind the logo is orange or green, your package is included in the recall.
- Check the lot number found adjacent to the expiration date (interior blister package) or embossed on the side panel under the Bayer logo on the exterior carton.
- Products with matching lot numbers: For example, Lot #296939L, UPC#: 016500537779.
| Product Name | Package Size | UPC # | Lot # | Logo Background |
|---|---|---|---|---|
| Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels | 20 capsules (12 day, 8 night) | 016500537779 | 296939L | Orange or Green |
| Other affected Alka-Seltzer Plus packages (see store list) | Varies | See individual packaging | Variable (see lot) | Orange or Green |
Details of Affected Products
- Recalled products are intended for temporary relief of symptoms associated with cold and flu, such as cough, congestion, fever, and mucus.
- Only select lots of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels and similar products are impacted.
- Effervescent products and individually packaged day or night formula products not in the affected lots are not subject to this recall.
Actions Taken by Bayer and Retailers
Following discovery of the labeling error, Bayer immediately started electronic notification of retailers, organized return procedures for affected packages, and set up direct consumer support channels.
- Retailers were instructed to remove affected products from shelves starting February 2018.
- Bayer offered consumers full refunds and support through their designated recall hotline: 1-800-986-0369, Monday through Friday, 9:00 AM–5:00 PM ET.
- Bayer also encouraged customers to report any experiences or adverse reactions directly to their service team to ensure consumer safety and tracking.
What Consumers Should Do Next
If you believe you have purchased a recalled Alka-Seltzer Plus product, the recommended steps are:
- Immediately stop using the product.
- Confirm your package by checking the logo, lot number, and background color as described above.
- Contact Bayer at 1-800-986-0369 or visit their official recall page for instructions on obtaining a refund, reporting issues, or getting more information.
- If you or someone in your household experience symptoms of an allergic or adverse reaction after use, contact your healthcare provider or seek medical attention promptly.
So far, Bayer reports no adverse events or injuries linked to the labeling error, but consumer vigilance is advised.
FDA and Regulatory Involvement
The U.S. Food and Drug Administration (FDA) closely monitored the recall and provided public notifications to raise awareness.
- The FDA notes the possibility for serious health consequences due to mislabeling, including ingestion of substances that may trigger allergies or be contraindicated for individual consumers.
- FDA guidance also tells consumers to be mindful of packaging details, ingredient lists, and to rely on updates from Bayer and their pharmacy.
History: Previous Alka-Seltzer Plus Recalls
This incident was not the first for Bayer’s Alka-Seltzer Plus line:
- August 2017 Recall: Bayer voluntarily recalled over one million Alka-Seltzer Plus cartons due to consumer complaints of small holes and cracks in the foil blister packs, which could compromise safety and efficacy.
- This earlier recall involved products manufactured at a German plant and was initiated following direct customer feedback.
Both instances underline the importance Bayer places on proactive quality assurance and consumer safety.
Frequently Asked Questions (FAQs)
Q: Why is Bayer recalling Alka-Seltzer Plus?
A: Bayer identified a packaging and labeling error where the ingredients listed on the front sticker may not match the actual tablets inside the carton. This mislabeling poses health risks for certain consumers, prompting a voluntary recall.
Q: Which stores sold the affected Alka-Seltzer Plus packages?
A: The packages were distributed nationwide at retail stores such as Walmart, CVS, Walgreens, and Kroger (including affiliated banner stores).
Q: How do I know if my product is part of the recall?
A: Check the background color behind the Bayer logo on the front lower left of the carton (orange or green indicates recall). Alternatively, match the lot number or UPC code as listed earlier in this guide.
Q: Is it safe to use Alka-Seltzer Plus products not included in the recall?
A: Yes. The recall does not affect effervescent Alka-Seltzer products or individually packaged day/night formulas not in the specified lots. Always read packaging thoroughly and consult your pharmacist for guidance.
Q: What should I do if I have medical symptoms after taking the recalled product?
A: Immediately contact your healthcare provider or emergency services if you experience symptoms such as swelling, difficulty breathing, hives, or other allergic reactions. Report your experience to Bayer using their recall hotline.
Additional Resources & Contact Information
- Bayer Recall Hotline: 1-800-986-0369 (Monday – Friday, 9:00 AM – 5:00 PM ET).
- FDA Recall Database: For official FDA updates and recall notices.
- Pharmacy or Healthcare Provider: For questions about alternative products and medical advice related to recalled medicine.
- Bayer’s Consumer Care Website: For direct information about the recall, refund procedures, and safety updates.
Conclusion
The voluntary recall of select Alka-Seltzer Plus products by Bayer highlights the critical importance of accurate packaging and consumer safety in the pharmaceutical industry. While no injuries have been reported, consumers are urged to check their medicine cabinets for affected products, contact Bayer if necessary, and always verify package labeling when purchasing over-the-counter medications. Bayer’s swift response demonstrates their commitment to public health and transparency.
SEO Optimized Summary Table
| Recall Reason | Mislabeling may cause allergic or contraindicated ingredient ingestion |
|---|---|
| Products Affected | Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels (select lots) |
| Stores Involved | Walmart, CVS, Walgreens, Kroger, and affiliated stores |
| Consumer Action | Stop using, check packaging, contact Bayer for refund |
| Health Risk | Potential allergic or adverse reaction from mislabeled ingredients |
References
- https://www.biospace.com/b-bayer-consumer-care-b-voluntarily-recalls-one-lot-of-combination-package-of-alka-seltzer-plus-r-day-and-night-cold-formula-liquid-gels-single-lot
- https://www.packagingdigest.com/pharmaceutical-packaging/bayer-voluntarily-recalls-combination-package-of-alka-seltzer-plus
- https://www.pharmamanufacturing.com/sector/over-the-counter/news/11307831/bayer-recalls-alka-seltzer-due-to-packaging-issues-again
- https://www.newson6.com/story/5e35e4f02f69d76f62020c44/labeling-error-leads-to-alkaseltzer-plus-recall
- https://www.goodhousekeeping.com/health/news/a48201/bayer-alka-seltzer-recall/
- https://www.einnews.com/pr_news/651206487/bayer-issues-voluntary-recall-of-alka-seltzer-plus-products
- https://www.drugtopics.com/view/alka-seltzer-plus-products-recalled
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