Recall archive / FDA drug enforcement

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Ai... — FDA record D-0483-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason: cGMP deviations
Classification: Class II
Recalling firm: Ultra Seal Corporation
Quantity: 7,858,690 packets
Agency-reported status: Terminated
Source record identifier: D-0483-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 9, 2022
Recall initiation date: Jan 24, 2022
Center classification date: Jan 31, 2022
Termination date: Oct 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.