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.
Labeling errors & mix-ups
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose.
1,411 FDA drug recalls with this cause, newest first.
This is exactly what it sounds like: the wrong label on the right product, the wrong strength printed on the bottle, a missing or illegible lot number and expiry date, or two products mixed up during packaging. It is dangerous precisely because the pill or liquid itself may be fine, yet the patient has no way of knowing what they are actually taking. A high share of the Class I recalls in this group are mix-ups where a stronger product ended up in a weaker product's packaging.
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.
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 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.
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