The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0484-2022·Announced 2022-02-09

Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations

Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.

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, a manufacturing compliance issue. The source text does not report any illnesses, injuries, or hospitalization, and the hazard is procedural rather than involving a known contaminant or allergen. Per the rubric, Class II recalls without reported harm typically score 2 (Moderate).

Plain-English summary

Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) tablets manufactured for First Aid Direct in Mason, Ohio. The product is supplied as 2 tablets per packet, with NDC 42961-0206-02.

The recall was initiated on January 24, 2022, due to current good manufacturing practice (cGMP) deviations identified in the manufacturing process. This is a voluntary, firm-initiated Class II recall. Affected lots include #9445, AK9445, K9445 (expiration 01/2022); K9486 (expiration 02/2022); AK9708 (expiration 07/2022); AK9515 (expiration 03/2022); K9810 (expiration 09/2022); and AK9658 (expiration 06/2022).

Approximately 5,741,384 packets were distributed nationwide within the United States. Consumers in possession of affected lots should discontinue use and consult their healthcare provider with questions. The FDA classified this recall on January 31, 2022, and the recall was terminated on October 16, 2023.

The recalled product

Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Combination Analgesic/Decongestant
Hazard
Affected units
5,741,384

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 (14)

  • Lot #: 9445
  • AK9445
  • K9445
  • Exp. Date 01/2022
  • K9486
  • Exp. Date 02/2022
  • AK9708
  • Exp. Date 07/2022
  • AK9515
  • Exp. Date 03/2022
  • K9810
  • Exp. Date 09/2022
  • AK9658
  • Exp. Date 06/2022

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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