AERO TAB Cold Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling AERO TAB Cold Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 226,390 packets of the product distributed nationwide.
What this means for you
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—manufacturing process violations. The source text does not report any illnesses, injuries, or confirmed harm. cGMP violations are regulatory/quality defects without established health impact, placing this in the Moderate category.
Plain-English summary
Ultra Seal Corporation is recalling AERO TAB Cold Relief, a multi-ingredient cold remedy containing acetaminophen 325 mg, Guaifenesin 200 mg, and Phenylephrine HCl 5 mg. The product is supplied in 2-tablet packets and is manufactured for Aero Healthcare of Valley Cottage, New York.
The recall was initiated due to cGMP deviations—violations of current Good Manufacturing Practice standards. The affected lot is #AK9565 with an expiration date of April 2022. A total of 226,390 packets were distributed nationwide within the United States.
Ultra Seal Corporation initiated this recall voluntarily by letter to the FDA on January 24, 2022. The FDA classified the recall as Class II on January 31, 2022. Consumers who have this product should discontinue use and contact the recalling firm for instructions on return or disposal. The recall was terminated on October 16, 2023.
The recalled product
- Product
- AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
- Manufacturer
- Ultra Seal Corporation
- Hazard
- manufacturing-practice-deviation
- cgmp-violation
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 #: AK9565
- Exp. Date 04/2022
Distribution
Distributed nationwide across the United States.
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