Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0507-2022·Announced 2022-02-09

Exaprin Pain Reliever Tablets Recalled for cGMP Deviations

Ultra Seal Corporation is recalling Exaprin pain reliever tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects approximately 1.14 million packets distributed across the United States.

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 based on cGMP deviations without any reported illnesses, injuries, or hospitalization. Per the rubric, this falls into the Moderate category as a voluntary precautionary recall with manufacturing deficiency concerns that have not resulted in reported harm.

Plain-English summary

Ultra Seal Corporation, manufacturing for HARTHealth of Seattle, Washington, is recalling Exaprin pain reliever tablets in 2-tablet packets (containing acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4 mg, and salicylamide 152 mg) nationwide within the United States. The recall was initiated on January 24, 2022, and involves approximately 1,140,1641 packets with Lot # AK9796 and expiration date 09/2022.

The reason for this recall is cGMP (current good manufacturing practices) deviations, as classified by the FDA as Class II. This is a voluntary recall initiated by the firm, with the FDA making its center classification determination on January 31, 2022. The recall was terminated on October 16, 2023.

No specific instructions for consumer action are provided in the recall notice beyond the termination date. Consumers with questions about this product should contact the manufacturer or the FDA's drug safety reporting channels.

The recalled product

Product: Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
Manufacturer: Ultra Seal Corporation
Category: Drug — Over-the-counter pain reliever
Hazard: cgmp-deviation
manufacturing-deficiency
Affected units: 11,401,641

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 #: AK9796
Exp. Date 09/2022

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.

See all 56 products in this recall →

Same manufacturer · Ultra Seal Corporation

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