1,523 recalls · Class III, newest first
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
Reason Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Reason Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot..
Reason Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Reason Subpotent; 12 month time point for the active ingredient Phenylephrine HCl.
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in…
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in…
Reason Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in…
Reason Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test…
Reason Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they…
Reason Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Reason Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Reason Labeling: Missing label
Reason Discoloration; Product may not meet specifications for color description once reconstituted.
Reason Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Reason Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Reason Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Reason Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or…
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or…
Reason Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or…