Class III · Low risk
NORCO (Hydrocodone Bitartrate and Acetaminophen)
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
FDA Drug Recalls
1,590 recalls, newest first
Class II · Moderate risk
VELCADE (bortezomib)
Defective Container: Confirmed reports of loose vial crimps.
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 75 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Fentanyl Transdermal System. 25 mcg/h
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Class III · Low risk
Atorvastatin Calcium Tablets 40 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 20 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Atorvastatin Calcium Tablets 10 mg
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Class III · Low risk
Megestrol Acetate Oral Suspension
Subpotent Drug: Out of specification for assay (stability testing)
Class I · High risk
Limbrel500
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel250
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 500 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
Limbrel (flavocoxid 250 mg)
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
Class III · Low risk
Life Brand Clear Action Acne Treatment Concealer Stick
Superpotent drug: failed assay throughout the stick after 6 months stability.
Class III · Low risk
Cefuroxime
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Class II · Moderate risk
Mycamine (micafungin)
Labeling: Label Error on Declared Strength
Class III · Low risk
Ultane (sevoflurane)
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Class III · Low risk
Oxycodone Hydrochloride Tablets
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class II · Moderate risk
Aripiprazole Tablets
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II · Moderate risk
TAD Glutathione Whitening Kits lyophilized powder for injection
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk
Saluta Glutathione Whitening kits
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk
Ling Zhi capsules
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Class II · Moderate risk
Sterilized water for injections BP
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.