Agency classClass IIIOur severity:Low FDA (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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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: stability-failure
out-of-specification
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 →

Same manufacturer · Ultra Seal Corporation

See all →

Moderate
PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Exaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Moderate
Cold Tablet with Acetaminophen Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09

Same hazard · stability failure