RecallRadar

FDA Drug recall D-1512-2020

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Co…

On 2020-08-26 the FDA classified a Class III recall of Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Co… by Ultra Seal, citing failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1512-2020
ClassificationClass III
Statusterminated
Initiated2020-08-03
Published2020-08-26
Last updated2026-09-13 11:52 UTC
CompanyUltra Seal
DistributionIL, TX

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1512-2020%22

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