Class II · Moderate risk
Finasteride Plus 1.25mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
Estriol 8 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Estriol 6 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
D-Biotin 300 mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Calcium citrate tetrahydrate USP powder
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Cefdinir for Oral Suspension USP
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class I · High risk
Lemon Blossom Hand Sanitizer
Microbial contamination of non-sterile products: positive microbial contamination in product.
Class II · Moderate risk
Lidothol Patch
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Class I · High risk
Mystic Shield PROTECTION
Chemical Contamination: Presence of Undeclared Methanol
Class II · Moderate risk
Carbamazepine 200 mg Tablets
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Class II · Moderate risk
Cetrotide (cetrorelix acetate for Injection)
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Class II · Moderate risk
Saniderm ADVANCED HAND SANITIZER
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class I · High risk
Chlorhexidine Gluconate 0012 For Manufacturing
Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
Class I · High risk
All Clean Hand Sanitizer
Chemical Contamination: Product contains undeclared methanol.
Class I · High risk
ChlroraPrep One-Step
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
ChloraPrep With Tint
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
BD ChloraPrep Clear 3 mL Applicators
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class III · Low risk
Tecfidera (dimethyl fumarate)
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk
Nystatin Oral Suspension
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class I · High risk
Saniderm ADVANCED HAND SANITIZER
Chemical Contamination: Product contains undeclared methanol.
Class I · High risk
Herbzeedy
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Goodness Gurus
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
Goodness Gurus
Chemical contamination: product contains elevated levels of undeclared lead.
Class I · High risk
BC Hemp Co.
Chemical contamination: product contains elevated levels of undeclared lead.