Advance Formula Pain Reliever tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class III recall involving out-of-specification stability test results for an impurity (Salicylic Acid). Class III recalls are typically scored 1 or 2. The source text does not report any illnesses, injuries, or deaths, and the hazard is a manufacturing/quality issue rather than an active safety threat. A score of 2 reflects precautionary monitoring of a quality defect.
Plain-English summary
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets containing Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg, packaged as 2 tablets per packet. The recall affects 991,310 tablets manufactured for Advanced First Aid (Baltimore, MD) and American Safety & First Aid (Osceola, IN).
The recall was initiated due to failed stability specifications. Out-of-specification results were observed for Salicylic Acid, an Aspirin-related compound. The affected lots are: AK-9457 (expiration 22-Jan), AK-9521 (expiration 22-Mar), AK-9959 (expiration 22-Dec), and AK-1017 (expiration 23-Jan).
The product was distributed nationwide in the USA. Consumers who have purchased this product should stop using it and contact the manufacturer or healthcare provider with questions.
The recalled product
- Product
- Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561…
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 991,310
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 (8)
- Lot #: AK-9457
- exp. date 22-Jan
- AK-9521
- exp. date 22-Mar
- AK-9959
- exp. date 22-Dec
- AK-1017
- exp. date 23-Jan
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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