Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
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 III · Low risk
Testosterone Gel 1%
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
Class III · Low risk
Clobetasol Propionate Ointment USP 0.05%
Superpotent and Subpotent; low and high assay results
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Class II · Moderate risk
Sodium Chloride Injection
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk
Metformin HCl Extended Release Tablets USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Class I · High risk
Paroex (chlorhexidine gluconate)
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg
Failed Dissolution Specification
Class II · Moderate risk
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg
Failed Dissolution Specification
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP 100 mg.
Class III · Low risk
Olanzapine Orally Disintegrating Tablets
Subpotent
Class III · Low risk
Felodipine Extended Release Tablets
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Class II · Moderate risk
Vapor Ointment packaged in a) 1/8 oz
CGMP Deviations
Class II · Moderate risk
White Liniment packaged in a) 1 oz
CGMP Deviations
Class II · Moderate risk
Union (black)
CGMP Deviations
Class II · Moderate risk
Metformin HCL E/R 500 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk
Metformin Hydrochloride Extended Release 750 mg
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)