The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0492-2022·Announced 2022-02-09

Drug Recall: PAINAID Tablets for Manufacturing Deviations

Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.

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 involving cGMP manufacturing deviations. No illnesses, injuries, or deaths are reported in the source text, and the source does not specify the nature of the manufacturing defect beyond "cGMP deviations." Per the rubric, Class II recalls without reported harm typically score 2 (Moderate).

Plain-English summary

Ultra Seal Corporation is recalling PAINAID, a combination pain relief tablet containing acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4 mg, and salicylamide 152 mg, sold in 2-tablet packets. The product is distributed nationwide in the United States by ZEE Medical Distributors, LLC of Mason, Ohio. Approximately 2,336,600 packets are affected.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified in the manufacturing process. This is a voluntary recall initiated by the firm. The affected lots are Lot #AK9433 (Expiration Date 01/2022) and Lot #AK9749 (Expiration Date 08/2022).

Consumers in possession of affected PAINAID packets should stop using the product. The FDA classification for this recall is Class II. The recall was initiated on January 24, 2022, and terminated on October 16, 2023.

The recalled product

Product
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Manufacturer
Ultra Seal Corporation
Category
Drug — Pain Relief
Hazard
Affected units
2,336,600

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 #: AK9433
  • Exp. Date 01/2022
  • AK9749
  • Exp. Date 08/2022

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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