Class III · Low risk Terminated
Doxercalciferol Capsules 0.5mcg
Reason Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Refresh Tears
Reason Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Class II · Moderate risk Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estradiol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estrone
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection
Class II · Moderate risk Terminated
Alka-Seltzer Gold
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Extra Strength
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class II · Moderate risk Terminated
Alka-Seltzer Original
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
Class I · High risk Terminated
LaBri's Body Health Atomic
Reason Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Class III · Low risk Terminated
PrednisoLONE Oral Solution USP
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
hCG Body Shaper
Reason Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Class II · Moderate risk Terminated
Nystatin and Triamcinolone Acetonide Cream
Reason Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Class II · Moderate risk Terminated
Levonorgestrel Non-Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Ethinyl Estradiol Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Testosterone Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estrone Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estriol Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estradiol Non-Micronized
Reason cGMP Deviations; lack of quality assurance.
Class II · Moderate risk Terminated
Estradiol Micronized Bulk
Reason cGMP Deviations; lack of quality assurance.
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Olanzapine Tablets
Reason Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Class III · Low risk Terminated
Pilocarpine Hydrochloride Ophthalmic Solution 4%
Reason Failed Impurities/Degradation Specifications.