Cetafen acetaminophen tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.
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: This is an FDA Class II voluntary recall for cGMP deviations without reported illnesses or injuries. Class II recalls typically indicate a situation where use of the product may cause adverse health consequences or death, but the source text does not report any actual harm or hospitalizations.
Plain-English summary
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets. The affected product includes Lot #A-K-9668 (Exp. Date 06/2022) and Lot #A-K-9475 (Exp. Date 02/2022), manufactured for HARTHealth in Seattle, WA.
The recall was initiated due to current good manufacturing practice (cGMP) deviations. This is a voluntary recall initiated by the firm.
Approximately 915,770 packets were distributed nationwide within the United States. The Food and Drug Administration classified this as a Class II recall. Consumers with affected product should discontinue use and consult their healthcare provider with questions.
The recalled product
- Product
- Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
- Manufacturer
- Ultra Seal Corporation
- Hazard
- Affected units
- 915,770
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 #: A-K-9668
- Exp. Date 06/2022
- A-K-9475
- Exp. Date 02/2022
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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