CLASS I Drug recall · Reported 2 May 2018 · FDA Enforcement Report
All Alka-Seltzer Plus¿ packages recalled by Bayer HealthCare
Bayer HealthCare Pharmaceuticals is recalling All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC), distributed nationwide in the US. The recall was initiated on 15 Mar 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0697-2018
- FDA event ID
- 79555
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Whippany, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Mar 2018
- FDA classified
- 24 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
Timeline
| 15 Mar 2018 | Recall initiated by company | |
| 24 Apr 2018 | Classified by FDA | +40 days |
| 2 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 green background, the product is included in the recall.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Which lots are affected?
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 green background, the product is included in the recall
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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