Class III · Low risk
Acetaminophen
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
FDA Drug Recalls
362 recalls · Class III, newest first
Class III · Low risk
Acetaminophen Regular Strength
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Acetaminophen Extra Strength 500 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg
Labeling: Not Elsewhere Classified - Wrong NDC number
Class III · Low risk
Just Right 5000
LABELING: LABEL MIX-UP.
Class III · Low risk
Acetaminophen
Label mix-up: Carton incorrectly labeled.
Class III · Low risk
Sevelamer Carbonate for Oral Suspension 0.8g packets
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class III · Low risk
Complete 30C/200C Homeopathic Kit
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class III · Low risk
Tivicay PD
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III · Low risk
Cephalexin for Oral Suspension
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class III · Low risk
Fentanyl 1000mcg/100mL
Labeling: Wrong Barcode
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Tropicamide 1%
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class III · Low risk
Synthroid
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class III · Low risk
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
VANCOmycin HCI PF
Labeling: Not Elsewhere Classified
Class III · Low risk
Oxytocin synthetic
Labeling: Not Elsewhere Classified
Class III · Low risk
Clearasil Rapid Rescue Deep Treatment Pads
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
Class III · Low risk
Bendamustine HCl Injection
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.