Class I · High risk
Ketorolac Trom
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
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.
- Total recalls
- 1,788
- Class I (high risk)
- 50
- Currently ongoing
- 61
- Most recent
- Dec 27, 2019
Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Sumatriptan Succinate Tablets
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class II · Moderate risk
Theraflu Cough Relief
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Trimix Super
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Trimix Forte 4
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Trimix -A (713)
Lack of sterility assurance.
Class II · Moderate risk
Trimix (713)
Lack of sterility assurance.
Class II · Moderate risk
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
Testosterone Cyp 200mg/Ml Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion
Lack of sterility assurance.
Class II · Moderate risk
QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion
Lack of sterility assurance.