The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0469-2022·Announced 2022-02-09

Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations

Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.

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 recall for cGMP deviations without reported illnesses or injuries. The recall is voluntary and precautionary in nature, addressing manufacturing process defects rather than a confirmed product hazard.

Plain-English summary

Ultra Seal Corporation is recalling Extra Strength (ES) Pain Reliever tablets containing 500 mg acetaminophen in 2 tablet packets. The recall was initiated on January 24, 2022, and covers approximately 297,050 packets distributed nationwide within the United States.

The recall is due to Current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The affected product is Lot #AK9602 with expiration date 05/2022.

This is a voluntary recall initiated by the firm. The FDA classified this recall as Class II. The recall was terminated on October 16, 2023. Consumers who have purchased this product should discontinue use and consult with a healthcare provider or pharmacist if they have questions.

The recalled product

Product
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Analgesic
Hazard
Affected units
297,050

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 #: AK9602
  • Exp. Date 05/2022

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 →

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