Reported Feb 9, 2022 · Terminated

SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets,…

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?

  • SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets
  • Manufactured forTellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
Lot codes and dates
    • Lot #: AK9766
    • Exp. Date 08/2022
Amount recalled
122,400 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ultra Seal Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 6:36 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.