Is Acetaminophen recalled?
240 FDA recalls mention Acetaminophen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Acetaminophen.
Class II · Moderate risk Terminated May 2, 2019
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated May 2, 2019
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated Mar 7, 2019
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class III · Low risk Terminated Aug 21, 2018
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices…
Class III · Low risk Terminated May 24, 2018
Reason Labeling: Missing Label
Class II · Moderate risk Terminated May 7, 2018
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated May 7, 2018
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated May 7, 2018
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk Terminated Apr 24, 2018
Reason 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…
Class II · Moderate risk Terminated Apr 24, 2018
Reason 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…
Class III · Low risk Terminated Feb 2, 2018
Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Class II · Moderate risk Terminated Aug 22, 2017
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
Class III · Low risk Terminated Aug 17, 2017
Reason Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class II · Moderate risk Terminated Feb 22, 2017
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated Jan 18, 2017
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated Aug 8, 2016
Reason 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 Terminated Jul 7, 2016
Reason CGMP Deviations
Class III · Low risk Terminated Apr 22, 2016
Reason Labeling: Not elsewhere classified - count on the label was incorrect.
Class II · Moderate risk Terminated Mar 25, 2016
Reason Lack of Processing Controls
Class I · High risk Terminated Sep 25, 2015
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class I · High risk Terminated Sep 25, 2015
Reason Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
Class II · Moderate risk Terminated Sep 22, 2015
Reason Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Class III · Low risk Terminated Jun 30, 2015
Reason Failed Dissolution Specifications
Class I · High risk Terminated Apr 15, 2015
Reason 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…
Class I · High risk Terminated Apr 15, 2015
Reason 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…