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
58 recalls, newest first
Class III · Low risk
Epinephrine/Lidocaine HCl
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
Class III · Low risk
Scandonest 3% Plain
Labeling: Label mix-up
Class III · Low risk
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
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 III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk
Dextroamphetamine Saccharate
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class I · High risk
Smart Care HAND SANITIZER
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Class III · Low risk
Homeopathic Energy Catalyst
Labeling: Product Contains Undeclared API; Incorrect formulation
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 III · Low risk
Nicotine Gum
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
Class I · High risk
Tranexamic Acid Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Class I · High risk
Amiodarone Hydrochloride Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
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 III · Low risk
Red Cross Oral Pain
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.