Reported Aug 26, 2020 · Terminated

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets,…

Ultra Seal Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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?

  • Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets
  • Manufactured forConvenience Valet Glendale Heights, IL 60139
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
1K-8909, AK8909, Exp. Date 12/2020
2AK9507, Exp. Date 03/2021
3AK9072, Exp. Date 04/2021
4AK9102, AK9601, AK9679, Exp. Date 05/2021
5AK9145, K9145, Exp. Date 06/2021
6AK9743, AK9830, Exp. Date 07/2021
7AK9276, Exp. Date 09/2021
8AK9391, A9392, Exp. Date 12/2021
9AK9505, Exp. Date 02/2022
10AK9508, AK9509 Exp. Date 04/2022
Amount recalled
701,735 packets

This recall covers 2 products

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

Where it was sold

Why it was recalled

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 16, 2021 · Data as of Sep 19, 8:37 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.