Class II · Moderate risk
Finasteride Plus 1.25mg Capsule
Lack of Processing Controls (lack of assurance of conformity to specifications).
FDA Drug Recalls
181 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
Lidothol Patch
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
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 II · Moderate risk
Acetaminophen and Codeine Phosphate 300/30 mg tablet
cGMP Deviations
Class II · Moderate risk
Levothyroxin
Lack of Processing Control
Class II · Moderate risk
Betahistine 16 mg Capsule 180 capsules bottle
Lack of Processing Control
Class II · Moderate risk
Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository
Lack of Processing Control
Class II · Moderate risk
Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone w/Cosmetic HRT Base 20 mg
Lack of Processing Control
Class II · Moderate risk
Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar
Lack of Processing Control
Class II · Moderate risk
Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube
Lack of Processing Control
Class II · Moderate risk
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar
Lack of Processing Control
Class II · Moderate risk
Paregoric Alternate Elixir 300 mL bottle
Lack of Processing Control
Class II · Moderate risk
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control
Class II · Moderate risk
Bi-Est
Lack of Processing Control
Class II · Moderate risk
Bi-Est (8:2)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (50/50)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (50/50)
Lack of Processing Control
Class II · Moderate risk
Bi-Est (1:1)
Lack of Processing Control