The Recall Desk
LowFDA (Drugs)·D-1513-2020·Announced 2020-08-26

Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries.

Plain-English summary

Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets. The product was manufactured for Convenience Valet in Glendale Heights, IL. The recall was initiated because out-of-specification (OOS) results were observed for salicylic acid, an aspirin-related compound, indicating failed stability specifications.

The affected product was shipped to two distributors in Illinois and Texas. These distributors may have further repackaged and distributed the product. The recall includes specific lot numbers with expiration dates ranging from December 2020 to April 2022, including lots K-8909, AK8909, AK9507, AK9072, AK9102, AK9601, AK9679, AK9145, K9145, AK9743, AK9830, AK9276, AK9391, A9392, AK9505, AK9508, and AK9509.

Consumers should check their medication for the lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Manufacturer
Ultra Seal Corporation
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
701,735

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 (20)

  • Lot #: K-8909
  • AK8909
  • Exp. Date 12/2020
  • AK9507
  • Exp. Date 03/2021
  • AK9072
  • Exp. Date 04/2021
  • AK9102
  • AK9601
  • AK9679
  • Exp. Date 05/2021
  • AK9145
  • K9145
  • Exp. Date 06/2021
  • AK9743
  • AK9830
  • Exp. Date 07/2021
  • AK9276
  • Exp. Date 09/2021
  • AK9391

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Ultra Seal Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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