Class III · Low risk
Cetirizine hydrochloride
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
FDA Drug Recalls
1,293 recalls, newest first
Class II · Moderate risk
Rocuronium Bromide Injection 50mg/5 mL
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Class II · Moderate risk
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
Class I · High risk
Firvanq (vancomycin hydrochloride for oral solution)
Product Mix-up: Incorrect diluent component included in the kit.
Class II · Moderate risk
Trulicity (dulaglutide)
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class II · Moderate risk
Pi yen chin Ophthalmic Redness Reliever Drops Made in China
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class II · Moderate risk
Micafungin for Injection
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
Class III · Low risk
Bleomycin for Injection
Labeling: Not elsewhere classified: Mislabeling
Class II · Moderate risk
Venlafaxine Tablets
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
Class II · Moderate risk
Triamcinolone Acetonide Ointment USP
Correct Labeled Product Mispack
Class II · Moderate risk
Econazole Nitrate Cream 1%
Correct Labeled Product Mispack
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class III · Low risk
Ketamine HCl Injection Solution
Labeling: Incorrect Exp. Date: Incorrect BUD.
Class III · Low risk
Levetiracetam Tablets USP
Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Class II · Moderate risk
Native Fluoride Toothpaste for Sensitive Teeth
Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class I · High risk
1% Lidocaine HCl Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk
0.5% Bupivacaine Hydrochloride Injection
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class III · Low risk
Thiamine HCl Injection
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class II · Moderate risk
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
Telmisartan Tablets
Labeling: Label-mixup
Class I · High risk
heal the world
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.