Acetaminophen: 8 recalls on record

Recalled by 1 agency: FDA (8).

First recall on record: February 19, 2020. Most recent: September 3, 2025.

Risk classification: Class I: 3 · Class II: 5

Most recent recalls

DateAgencyProduct
September 3, 2025FDAAcetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, R…D-0596-2025
August 28, 2024FDAAcetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Int…D-0635-2024
August 14, 2024FDAAcetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Me…D-0631-2024
July 3, 2024FDAExtra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARM…D-0566-2024
August 24, 2022FDAAcetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single D…D-1348-2022
November 17, 2021FDAAcetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup:…D-0094-2022
May 12, 2021FDAAcetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Majo…D-0358-2021
February 19, 2020FDAMajor Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged …D-0858-2020

Questions about this brand

How many recalls does Acetaminophen have?
Recalert has 8 U.S. recalls on record for Acetaminophen, published between February 19, 2020 and September 3, 2025.
What was the most recent Acetaminophen recall?
FDA recall D-0596-2025, published September 3, 2025: Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.
Which agencies have recalled Acetaminophen products?
Acetaminophen products appear in recalls from: FDA (8).

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