Class II · Moderate risk
DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
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 II · Moderate risk
CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class III · Low risk
Oxycodone and Acetaminophen Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Labeling: Missing Label
Class II · Moderate risk
RPC APAP Elixir
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
RPC Children's Non-Aspirin
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class II · Moderate risk
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class II · Moderate risk
Ninjacof-A
Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class II · Moderate risk
Ofirmev (Acetaminophen)
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Ninjacof-A
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Acetaminophen 325mg tablets
CGMP Deviations
Class III · Low risk
Acetaminophen & Codeine Phosphate Tablets
Labeling: Not elsewhere classified - count on the label was incorrect.
Class II · Moderate risk
All Midrin
Lack of Processing Controls
Class I · High risk
ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk
ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class II · Moderate risk
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg)
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Class III · Low risk
Panadol (acetaminophen)
Failed Dissolution Specifications
Class I · High risk
Mucinex Fast-Max Cold & Sinus
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
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