18,003 recalls, newest first
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
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.
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
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
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
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
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.
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.
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.
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.
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.
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.
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.
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.
Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
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
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.