CLASS III Drug recall · Reported 26 Aug 2020 · FDA Enforcement Report

Extra Strength Headache Relief recalled by Ultra Seal

Ultra Seal is recalling Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg), distributed in Illinois, Texas. The recall was initiated on 3 Aug 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 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

Quantity recalled701,735 packets

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1513-2020
FDA event ID: 86264
Recalling firm: Ultra Seal, New Paltz, NY
Classification: Class III
Status: Terminated
Recall initiated: 3 Aug 2020
FDA classified: 20 Aug 2020
Reported: 26 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

3 Aug 2020	Recall initiated by company
20 Aug 2020	Classified by FDA	+17 days
26 Aug 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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,

Where it was distributed

Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

Illinois Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 86264

This product is part of a recall event; the main page for the event is Pain Relief Maximum Strength recalled by Ultra Seal.

Reported	Class	Recall	Company	Reason	Where
26 Aug 2020	CLASS III	Pain Relief Maximum Strength recalled by Ultra Seal	Ultra Seal	Potency & Assay	IL, TX

More recalls from Ultra Seal

All 66

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