Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
Is Acetaminophen recalled?
Yes — there is an active recall. 24 ongoing FDA recalls mention Acetaminophen (240 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Acetaminophen. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Acetaminophen recalls on record
none so far in 2026; 240 on record, newest first
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk
Acetaminophen 500 mg tablet
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk
Acetaminophen 325 mg tablets
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class II · Moderate risk
Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 650 mg / 20.3 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 160 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: Failure to properly investigate failed microbial testing.
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
Pain Aid PMF Caplet
CGMP Deviations
Class II · Moderate risk
Normed Fem Tablet
CGMP Deviations
Class II · Moderate risk
APAP 325 mg
CGMP Deviations
Class II · Moderate risk
Migrenol Caplet
CGMP Deviations
Class II · Moderate risk
HPC Tablet
CGMP Deviations
Class II · Moderate risk
APAP 500 mg SRC Coated
CGMP Deviations
Class II · Moderate risk
APAP 500 mg tablet
CGMP Deviations
Class II · Moderate risk
Extra-Strength Unaspirin caplet
CGMP Deviations
Class II · Moderate risk
Coated APAP 500 mg caplet
CGMP Deviations
Class II · Moderate risk
Normed APAP 325 mg
CGMP Deviations
Class II · Moderate risk
Coated APAP 325mg
CGMP Deviations
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