ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 6...

FDA Drug Recall #D-0072-2022 — Class III — October 13, 2021

Recall Summary

Recall Number D-0072-2022
Classification Class III — Low risk
Date Initiated October 13, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ultra Seal Corporation
Location New Paltz, NY
Product Type Drugs
Quantity 1,968,150 tablets

Product Description

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Reason for Recall

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot #: AK-9547, exp. date 22- Apr; AK-9941, exp. date 22-Dec

Other Recalls from Ultra Seal Corporation

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D-0497-2022 Class II Pain & Sinus Reliever Pain Reliever/Nasal Decon... Jan 24, 2022
D-0482-2022 Class II Backache & Muscle Relief (acetaminophen 250 mg,... Jan 24, 2022
D-0506-2022 Class II MidNite Natural sleep aid Chewable Tablets Cher... Jan 24, 2022
D-0481-2022 Class II Multi-Symptom Cramp Relief (acetaminophen 325mg... Jan 24, 2022
D-0487-2022 Class II COLD TERMINATOR decongestant/cold relief (aceta... Jan 24, 2022

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.