Reported Feb 9, 2022 · Terminated

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero…

Ultra Seal Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ultra Seal Corporation · 521 Main St · New Paltz, NY · 12561-1609

Is this the product you have?

    • AERO TAB Cold Relief (acetaminophen 325 mg
    • Guaifenesin 200mg
    • Phenylephrine HCl 5mg) 2 tablet packets
    • Mfg
  • forAero Healthcare, Valley Cottage, NY 10989
Lot codes and dates
    • Lot #: AK9565
    • Exp. Date 04/2022
Amount recalled
226,390 packets

This recall covers 56 products

The agency filed one notice per product. You are reading one of them; the other 55 are below.

43 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

cGMP deviations

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 16, 2023 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.