Acetaminophen Pain Reliever Recalled for cGMP Deviations
Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source classifies this as FDA Class II. The hazard is a manufacturing practice deviation without any reported illnesses, injuries, or deaths. The source text explicitly states the reason for recall is "cGMP deviations" with no indication of actual harm, making this a precautionary recall warranting a Moderate severity rating.
Plain-English summary
Ultra Seal Corporation is recalling approximately 1,236,000 packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) distributed nationwide in the United States. The affected product is the 2-tablet packet formulation manufactured for Advanced First Aid (Baltimore, MD) and American Safety & First Aid (Osceola, IN), with NDC 67060-210-68.
The recall was initiated due to current good manufacturing practice (cGMP) deviations identified at the manufacturing facility. The affected lots are AK9495 (expiration date 02/2022) and AK6413 (expiration date 05/2022).
This is a Class II recall initiated voluntarily by the firm on January 24, 2022. Consumers who have purchased this product should stop using it. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
- Manufacturer
- Ultra Seal Corporation
- Hazard
- manufacturing-deviation
- cgmp-violation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: AK9495
- Exp. Date 02/2022
- AK9613
- Exp. Date 05/2022
Distribution
Distributed nationwide across the United States.
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