Headache Relief Tablets (Ultra Seal) – stability specification failure (2020)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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,
Brand
Ultra Seal Corporation
Lot Codes / Batch Numbers
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, A9392, Exp. Date 12/2021, AK9505, Exp. Date 02/2022, AK9508, AK9509 Exp. Date 04/2022
Products Sold
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, A9392, Exp. Date 12/2021; AK9505, Exp. Date 02/2022; AK9508, AK9509 Exp. Date 04/2022
Ultra Seal Corporation is recalling Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-table due to Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN, TX
Page updated: Jan 7, 2026