Class II · Moderate risk
HGH Vitality Homeopathic
Labeling: Error on Declared Strength
FDA Drug Recalls
58 recalls, newest first
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 III · Low risk
Fosaprepitant for Injection
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Class II · Moderate risk
Vancomycin HCL 1.5 mg Edge Pharma
Labeling: Label Error on Declared Strength
Class III · Low risk
Nabumetone Tablets
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
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 III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Class III · Low risk
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
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.
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class III · Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.