Is Pseudoephedrine recalled?
43 FDA recalls mention Pseudoephedrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pseudoephedrine.
Class II · Moderate risk Terminated Jun 5, 2019
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or…
Class II · Moderate risk Terminated Jun 5, 2019
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or…
Class II · Moderate risk Terminated Jun 5, 2019
Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or…
Class II · Moderate risk Terminated May 21, 2019
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated May 21, 2019
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated May 21, 2019
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated May 21, 2019
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated May 21, 2019
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated Nov 8, 2017
Reason Microbial Contamination of Non-Sterile Products
Class III · Low risk Terminated May 23, 2016
Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient…
Class II · Moderate risk Terminated Dec 16, 2014
Reason Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40.
Class II · Moderate risk Terminated Feb 7, 2014
Reason Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 60 mg may be potentially mislabeled as REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree…
Class II · Moderate risk Terminated Jul 2, 2013
Reason Labeling: Label Mixup; PSEUDOEPHEDRINE HCL, Tablet, 30 mg may be potentially mislabeled as D-ALPHA TOCOPHERYL ACETATE, Capsule, 400 units, NDC…
Class II · Moderate risk Terminated Jun 18, 2013
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated Jun 18, 2013
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated Jun 18, 2013
Reason Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk Terminated Jan 30, 2013
Reason CGMP Deviations: Products are underdosed or have an incorrect dosage regime.