Class II · Moderate risk
Estriol 0.1%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Bi-Est (Estriol/Estradiol)
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Anastrozole SR 1 mg Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Anastrozole 0.5 mg Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class III · Low risk
Isradapine Capsules USP 2.5 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Fluconazole Injection
Superpotent
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class III · Low risk
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Failed Stability Specifications
Class I · High risk
GERICARE Eyewash
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
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.