D-0697-2018 Class I Terminated
FDA drug recall D-0697-2018 was initiated by Bayer HealthCare Pharmaceuticals, Inc. on Mar 15, 2018 and is designated Class I. 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… The recall status is terminated (terminated Jan 14, 2020). Affected quantity: 188,631 units.
Recall Details
- Product Type
- Drugs
- Report Date
- May 2, 2018
- Initiation Date
- Mar 15, 2018
- Termination Date
- Jan 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188,631 units
Product Description
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.
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.
Distribution Pattern
Nationwide in the USA
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0697-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026