Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets Recalled by Ultra Seal Corporation Due to Failed Stability Specifications: Out-of-Specification results observed for Aspirin...

Date: October 13, 2021
Company: Ultra Seal Corporation
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ultra Seal Corporation directly.

Affected Products

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Quantity: 2,484,274 tablets

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ultra Seal Corporation

Ultra Seal Corporation has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report