Class III · Low risk
AERO Tab PAIN RELIEVER
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
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
ZEE+ painaid ESF Extra-Strength Formula
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Vica-Cet BACK PAIN RELIEF
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
PainAway II
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class II · Moderate risk
Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk
Acetaminophen
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.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class III · Low risk
Benzhydrocodone and Acetaminophen Tablets
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class III · Low risk
Extra Strength Headache Relief
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Pain Relief Maximum Strength
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen and Codeine Phosphate Tablets
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Class II · Moderate risk
Acetaminophen 500 mg tablet packaged in a) 30-count bottles
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Class II · Moderate risk
Major Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk
Leader Extra Strength Acetaminophen Tablets
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Class II · Moderate risk
Acetaminophen Children's Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Pain & Fever Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Mapap Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Children's Acetaminophen Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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