AYPANAL Pain Reliever Tablets Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling AYPANAL Non-aspirin Pain Reliever tablets (acetaminophen 325 mg) in 2-count packets nationwide due to Current Good Manufacturing Practice (cGMP) deviations.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The source classifies this as FDA Class II with no reported illnesses or injuries. The hazard is manufacturing deviation (cGMP non-compliance), which is a quality/process issue rather than direct contamination or acute harm. No hospitalization reports or injury reports are mentioned, placing this in the Moderate category per the rubric.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets in 2-count packets distributed nationwide in the United States. The recall was initiated on January 24, 2022, and involves approximately 216,000 packets.
The recall is due to Current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The affected product is identified by Lot #: AK9640 with an expiration date of 03/2022.
Consumers should discontinue use of affected packets and consult a healthcare provider with any questions or concerns about this product.
The recalled product
- Product
- AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 216,000
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 (2)
- Lot #: AK9640
- Exp. Date 03/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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