The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0697-2018·Announced 2018-05-02

Bayer Recalls Alka-Seltzer Plus Packages Due to Ingredient Label Mismatch

Bayer is recalling specific Alka-Seltzer Plus packages because the ingredients listed on the front sticker may not match the actual product inside the carton.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it poses a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Bayer HealthCare Pharmaceuticals, Inc. is recalling all Alka-Seltzer Plus packages that feature a green or orange Bayer logo on the lower left corner of the front of the carton. The recall involves 188,631 units distributed nationwide in the USA.

The recall is being issued because the ingredients listed on the front sticker of these specific packages may not match the actual product contained within the carton. This labeling discrepancy creates a risk for consumers who rely on the front panel information to determine product contents.

Consumers should check the Bayer logo on the lower left corner of the front of their Alka-Seltzer Plus cartons. If the logo has an orange or green background, the product is included in the recall. Consumers should stop using these products and contact Bayer for further instructions.

The recalled product

Product
All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products 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…
Affected units
188,631

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • the product is included in the recall

Distribution

Distributed nationwide across the United States.

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