Class II · Moderate risk
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Labeling: Missing instructions for use insert
FDA Drug Recalls
26 recalls · Class II, newest first
Class II · Moderate risk
N-A-C
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Class II · Moderate risk
Killz Germz Hand Sanitizer
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class II · Moderate risk
Killz Germz Hand Sanitizer
Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.
Class II · Moderate risk
Prednisone Tablets
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Class II · Moderate risk
Just Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
Always Be Clean Hand Sanitizer
Labeling Not Elsewhere Classified: Product labeled to contain methanol
Class II · Moderate risk
Leiper's Fork Distillery
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Class II · Moderate risk
HGH Vitality Homeopathic
Labeling: Error on Declared Strength
Class II · Moderate risk
Lidocaine Patch 5%
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class II · Moderate risk
Vancomycin HCL 1.5 mg Edge Pharma
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Aripiprazole Tablets
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Class II · Moderate risk
Gaviscon Liquid Antacid Extra Strength
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Regular Strength Liquid Antacid Cool Mint
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Gaviscon Regular Strength Liquid Antacid Cool Mint
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Class II · Moderate risk
Lisinopril Tablets
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Dextroamphetamine Saccharate
Some bottles may contain mixed strengths of the product.
Class II · Moderate risk
Lisinopril Tablets USP
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Class II · Moderate risk
Advil Liqui-Gel Mini 160+20+20 CT
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.