Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid...
FDA Drug Recall #D-1050-2017 — Class II — March 30, 2017
Recall Summary
| Recall Number | D-1050-2017 |
| 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 | 24,672 24-count cartons |
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
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
BTAHDG0; Exp. 04/19
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-1051-2017 | Class II | Alka-Seltzer Gold (1000 mg Anhydrous citric ac... | 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.