Class III · Low risk
Zarontin (ethosuximide capsules, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
FDA Drug Recalls
1,293 recalls, newest first
Class III · Low risk
ethosuximide capsules
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class I · High risk
Quinacrine Dihydrochloride
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class II · Moderate risk
Ascorbic Acid Sterile Injection Solution
Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.
Class III · Low risk
Lamivudine Tablets
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class III · Low risk
Simvastatin Tablets
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Missing label; Product complaints reported missing bottle label.
Class III · Low risk
Myorisan (isotretinoin capsules, USP)
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class I · High risk
Pecgen DMX Cough Suppressant Expectorant
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Class II · Moderate risk
Amitiza (lubiprostone)
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk
Amitiza (lubiprostone)
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk
Articaine DENTAL
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Class III · Low risk
Relpax (eletriptan HBr)
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class III · Low risk
Dermoplast Anesthetic PAIN & ITCH
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class II · Moderate risk
Carvedilol Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Acyclovir Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class I · High risk
FENTANYL Transdermal System
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class III · Low risk
Clonidine HCL Injection
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Class II · Moderate risk
Phenobarbital Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk
Gavilyte-N
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk
MAGnesium 2 gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
Class II · Moderate risk
MAGnesium 2gm sulfate
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.