Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg ...

FDA Drug Recall #D-1051-2017 — Class II — March 30, 2017

Recall Summary

Recall Number D-1051-2017
Classification Class II — Moderate risk
Date Initiated March 30, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bayer HealthCare Pharmaceuticals, Inc.
Location Morristown, NJ
Product Type Drugs
Quantity 56,064 36-count cartons

Product Description

Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085

Reason for Recall

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

Distribution Pattern

Nationwide

Lot / Code Information

BTAHGR0; Exp. 05/19 BTAHGR1; Exp. 05/19 BTAHGR2; Exp. 05/19 BTAJ0K3; Exp. 07/19

Other Recalls from Bayer HealthCare Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0697-2018 Class I All Alka-Seltzer Plus¿ packages with a full fro... Mar 15, 2018
D-0590-2018 Class II Coppertone Kids Sunscreen Spray (avobenzone 3%,... Feb 23, 2018
D-0135-2018 Class III Bayer Chewable Low Dose Aspirin 81 mg Orange Fl... Nov 10, 2017
D-1044-2017 Class II Alka-Seltzer Original ( 325 mg Aspirin (NSAID),... Mar 30, 2017
D-1050-2017 Class II Alka-Seltzer Extra Strength (500 mg Aspirin (NS... Mar 30, 2017

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.