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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86264

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 03, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ultra Seal Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007

D-1512-2020
Recall number
D-1512-2020
Initiated
August 03, 2020
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
4,666,355 packets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: AK8745, Exp. Date 08/20; AK9751, Exp. Date 08/2021; AK9552, Exp. Date 04/2022

Distribution pattern

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

drug · product 2 of 2

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,

D-1513-2020
Recall number
D-1513-2020
Initiated
August 03, 2020
Classification
Class III
Status
Terminated
Recalling firm
Ultra Seal Corporation
Quantity
701,735 packets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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