Class I · High risk
Panther Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class I · High risk
Rhino 7 Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Stallion Platinum 30000 Capsules in blue
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class I · High risk
Bull Platinum 30000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Hydrocortisone and Acetic Acid Otic Solution
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Class III · Low risk
Class III · Low risk
Class III · Low risk
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Estriol
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class II · Moderate risk
Estriol
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Class I · High risk
Levetiracetam Oral Solution 100mg/mL
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Class II · Moderate risk
Raloxifene Hydrochloride Tablets
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.