Class III · Low risk
Enoxaparin Sodium
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Bull Capsules
Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil
Class III · Low risk
Penicillin V Potassium for Oral Solution
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Class III · Low risk
Duloxetine Delayed-Release Capsules USP
Failed Dissolution Specification
Class III · Low risk
Isradapine Capsules USP 2.5 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluconazole Injection
Superpotent
Class III · Low risk
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Failed Stability Specifications
Class III · Low risk
Ciprofloxacin in Dextrose
Superpotent
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
Dexamethasone Sodium Phosphate Injection
Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk
bupPROPion HCL Extended-Release Tablets
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Class III · Low risk
Meclizine hydrochloride tablets USP
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class III · Low risk
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Methylphenidate Hydrochloride Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution.
Class III · Low risk
Clofarabine injection
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class III · Low risk
Clolar (clofarabine)
Labeling: Incorrect or Missing Package Insert.
Class III · Low risk
Famotidine tablets
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Class III · Low risk
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Ampicillin for Injection
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.