Recall Record

Libertyville, IL, United States

A-S Medication Solutions LLC. recalls

5 recalls recorded since 2018, most recently on 25 February 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)2

Ongoing Class II Drugs

Recall started
25 February 2025
Reason
Presence of Foreign Tablets/Capsules.
Distribution
Nationwide in U.S.
Initiated
Voluntary: Firm initiated
Recall number
D-0292-2025

Terminated Class I Drugs

Recall started
21 June 2024
Terminated
7 May 2025
Reason
Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Distribution
Nationwide within the United States.
Initiated
Voluntary: Firm initiated
Recall number
D-0631-2024

Terminated Class III Drugs

Recall started
5 October 2021
Terminated
12 August 2022
Reason
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Distribution
FL, IN, MN, WI
Initiated
Voluntary: Firm initiated
Recall number
D-0096-2022

Terminated Class I Drugs

Recall started
2 March 2021
Terminated
23 April 2025
Reason
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Distribution
Nationwide in the USA
Initiated
Voluntary: Firm initiated
Recall number
D-0358-2021

Ongoing Class II Drugs

Recall started
17 July 2018
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Nationwide USA
Initiated
Voluntary: Firm initiated
Recall numbers
D-1111-2018, D-1109-2018, D-1110-2018, D-1108-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.