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Class II: temporary or reversible health riskTerminated

Bayer HealthCare Pharmaceuticals Alka-Seltzer Extra Strength Recall

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbona…

Bayer HealthCare Pharmaceuticals, Inc. · Morristown, NJ

Risk level
Class II
Reported by FDA
Aug 9, 2017
Recall ID
D-1050-2017
Check your lot numberHow we source this data

Summary

Bayer HealthCare Pharmaceuticals recalled Alka-Seltzer Extra Strength starting Mar 30, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1050-2017 on Aug 9, 2017. Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. Status: Terminated.

Why it was recalled

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Product description

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048

Lot numbers, UPCs & expiration codes

BTAHDG0; Exp. 04/19

Where it was sold

Nationwide

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-1050-2017
Classification
Class II
Status
Terminated
Recall initiated
Mar 30, 2017
FDA report date
Aug 9, 2017
Quantity
24,672 24-count cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1050-2017, exactly as published.

Show all FDA fields
City
Morristown
State
NJ
Status
Terminated
Country
United States
Event ID
77484
Address
36 Columbia Rd
Code information
BTAHDG0; Exp. 04/19
Postal code
07960-4526
Report date
Aug 9, 2017
Product type
Drugs
Recall number
D-1050-2017
Classification
Class II
Recalling firm
Bayer HealthCare Pharmaceuticals, Inc.
Product quantity
24,672 24-count cartons
Termination date
Jan 8, 2020
Reason for recall
Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
Distribution pattern
Nationwide
Recall initiation date
Mar 30, 2017
Initial firm notification
Letter
Center classification date
Aug 1, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1050-2017, published Aug 9, 2017. 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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