Class II · Moderate risk
Sodium Phosphate Dibasic/Water for Injection 10%
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
FDA Drug Recalls
14,806 recalls, newest first
Class III · Low risk
Clobetasol Propionate Cream
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Class II · Moderate risk
DIANEAL Low Calcium
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Class II · Moderate risk
Terazosin Hydrochloride Capsules
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Class II · Moderate risk
Olanzapine Tablets
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Class I · High risk
METHA-DROL Extreme capsules
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Class I · High risk
Super-DMZ Rx 2.0 Capsules
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Class I · High risk
B-50 capsules
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Class III · Low risk
Tagitol V Barium Sulfate Suspension
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Class III · Low risk
Oxycodone and Acetaminophen Capsules
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Class I · High risk
Volcano Male Enhancement 1500mg
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Class I · High risk
Volcano Male Enhancement Liquid
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Class I · High risk
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelder Siloutte Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelin Siloutte Te
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class III · Low risk
Tums
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Class III · Low risk
Alcohol Free Antiseptic
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Class II · Moderate risk
Acyclovir Tablets USP 800 mg
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Class III · Low risk
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Class I · High risk
0.75% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class I · High risk
0.25% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Class II · Moderate risk
Nystatin Oral Suspension
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Class II · Moderate risk
DayQuil Sinex DayTime Sinus Relief
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.