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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Ultra Seal Corporation: Headache and Pain Relief Tablets Recalled for Failed Stability Specifications

Agency Publication Date: August 20, 2020
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Summary

Ultra Seal Corporation is recalling over 5.3 million packets of Pain Relief Maximum Strength and Extra Strength Headache Relief tablets (containing acetaminophen, aspirin, and caffeine). The recall was initiated because routine testing found the products failed stability specifications due to elevated levels of salicylic acid, which is a compound related to the breakdown of aspirin. These products were sold in 2-tablet packets under the brand names Select Corporation and Convenience Valet. Consumers who have these products should check their lot numbers and expiration dates to see if they are affected.

Risk

The elevated levels of salicylic acid indicate that the aspirin in the tablets is degrading or breaking down faster than intended. While this poses a low risk to health, it means the medication may not meet the required quality and potency standards through its listed expiration date.

What You Should Do

  1. Check your medication packets for the following product names: 'Pain Relief Maximum Strength' or 'Extra Strength Headache Relief' distributed in 2-tablet packets.
  2. For Pain Relief Maximum Strength, check for lot numbers AK8745 (Exp. 08/20), AK9751 (Exp. 08/2021), or AK9552 (Exp. 04/2022).
  3. For Extra Strength Headache Relief, check for lot numbers K-8909 or AK8909 (Exp. 12/2020); AK9507 (Exp. 03/2021); AK9072 (Exp. 04/2021); AK9102, AK9601, or AK9679 (Exp. 05/2021); AK9145 or K9145 (Exp. 06/2021); AK9743 or AK9830 (Exp. 07/2021); AK9276 (Exp. 09/2021); AK9391 or A9392 (Exp. 12/2021); AK9505 (Exp. 02/2022); and AK9508 or AK9509 (Exp. 04/2022).
  4. Contact your healthcare provider or pharmacist for guidance regarding the continued use of these products.
  5. Return any unused, affected packets to the place of purchase for a refund and contact Ultra Seal Corporation for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consumers should return the affected medication packets to the place of purchase for a full refund.

Affected Products

Product: Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet
Model:
D-1512-2020
Lot Numbers:
AK8745 (Exp. Date 08/20)
AK9751 (Exp. Date 08/2021)
AK9552 (Exp. Date 04/2022)
Date Ranges: 08/2020, 08/2021, 04/2022
Product: Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets
Model:
D-1513-2020
Lot Numbers:
K-8909 (Exp. Date 12/2020)
AK8909 (Exp. Date 12/2020)
AK9507 (Exp. Date 03/2021)
AK9072 (Exp. Date 04/2021)
AK9102 (Exp. Date 05/2021)
AK9601 (Exp. Date 05/2021)
AK9679 (Exp. Date 05/2021)
AK9145 (Exp. Date 06/2021)
K9145 (Exp. Date 06/2021)
AK9743 (Exp. Date 07/2021)
AK9830 (Exp. Date 07/2021)
AK9276 (Exp. Date 09/2021)
AK9391 (Exp. Date 12/2021)
A9392 (Exp. Date 12/2021)
AK9505 (Exp. Date 02/2022)
AK9508 (Exp. Date 04/2022)
AK9509 (Exp. Date 04/2022)
Date Ranges: 12/2020, 03/2021, 04/2021, 05/2021, 06/2021, 07/2021, 09/2021, 12/2021, 02/2022, 04/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86264
Status: Resolved
Manufacturer: Ultra Seal Corporation
Sold By: Select Corporation; Convenience Valet
Manufactured In: United States
Units Affected: 2 products (4,666,355 packets; 701,735 packets)
Distributed To: Illinois, Texas

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.