The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0483-2022·Announced 2022-02-09

Drug Recall: Cold Relief Tablets Due to cGMP Deviations

Ultra Seal Corporation is voluntarily recalling Cold Relief tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product is distributed nationwide in 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 recall involving cGMP deviations, a manufacturing process deviation rather than a direct hazard to consumers. No illnesses or injuries are reported in the source text, and the hazard is related to manufacturing compliance rather than product contamination or structural defect.

Plain-English summary

Ultra Seal Corporation is voluntarily recalling Cold Relief (acetaminophen 250 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg), sold as 2 tablets per packet and manufactured for First Aid Direct in Mason, Ohio. The recall affects 7,858,690 packets distributed nationwide within the United States.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. The affected lots include: K9456, AK9454, 9456, AK9456 (Exp. 01/2022); AK9524, AK9528 (Exp. 03/2022); K9767, AK9767 (Exp. 08/2022); AK9824, AK9823 (Exp. 09/2022); and AK9564 (Exp. 04/2022).

Consumers who have this product should stop using it. Those with questions about the recall should contact Ultra Seal Corporation or their healthcare provider. The recall was initiated on January 24, 2022, and was terminated on October 16, 2023.

The recalled product

Product
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Cold/Flu Relief
Hazard
Affected units
7,858,690

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 (15)

  • Lot #: K9456
  • AK9454
  • 9456
  • AK9456
  • Exp. Date 01/2022
  • AK9524
  • AK9528 Exp. Date 03/2022
  • K9767
  • AK9767
  • Exp. Date 08/2022
  • AK9824
  • AK9823
  • Exp. Date 09/2022
  • AK9564
  • Exp. Date 04/2022

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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