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Class I: serious health riskTerminated

Bayer HealthCare Pharmaceuticals All Alka-Seltzer Plus¿ packages with a full Recall

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC)…

Bayer HealthCare Pharmaceuticals, Inc. · Whippany, NJ

Risk level
Class I
Reported by FDA
May 2, 2018
Recall ID
D-0697-2018
Check your lot numberHow we source this data

Summary

Bayer HealthCare Pharmaceuticals recalled All Alka-Seltzer Plus¿ packages with a full starting Mar 15, 2018. The FDA classified it as Class I (serious health risk) and published enforcement report D-0697-2018 on May 2, 2018. Reason: 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. Status: Terminated.

Why it was 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.

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.

Lot numbers, UPCs & expiration codes

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 sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0697-2018
Classification
Class I
Status
Terminated
Recall initiated
Mar 15, 2018
FDA report date
May 2, 2018
Quantity
188,631 units
Recall type
Voluntary: Firm initiated
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-0697-2018, exactly as published.

Show all FDA fields
City
Whippany
State
NJ
Status
Terminated
Country
United States
Event ID
79555
Address
100 Bayer Blvd
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
Postal code
07981-1544
Report date
May 2, 2018
Product type
Drugs
Recall number
D-0697-2018
Classification
Class I
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.
Product quantity
188,631 units
Termination date
Jan 14, 2020
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.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Mar 15, 2018
Initial firm notification
Press Release
Center classification date
Apr 24, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0697-2018, published May 2, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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