Sinus Decongestant Nasal Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.
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 initiated voluntarily by the firm for cGMP deviations. The source text does not report any illnesses, injuries, or specific health hazards—only manufacturing practice violations. Per the rubric, manufacturing/compliance issues without reported harm are typically classified as Moderate.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling SINUS DECONGESTANT Nasal Decongestant tablets containing phenylephrine HCl 5mg in 2-count packets distributed by Honeywell Safety Products USA. The recall involves 448,300 packets distributed nationwide within the United States.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations. Lot #AK9859 with an expiration date of 10/2022 is affected.
Consumers who have purchased this product should stop use. More information is available from the FDA or by contacting the recalling firm, Ultra Seal Corporation. This is a Class II recall that was terminated on October 16, 2023.
The recalled product
- Product
- SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Nasal Decongestant
- Affected units
- 448,300
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 #: AK9859
- Exp. Date 10/2022
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.
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