Class I · High risk
Natpara (parathyroid hormone)
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
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 III · Low risk
Zarontin (ethosuximide capsules, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk
ethosuximide capsules
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Failed Impurities/Degradation Specificattion
Class II · Moderate risk
Nucala (mepolizumab)
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Class II · Moderate risk
Anagrelide Capsules
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Assurance of Sterility
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class III · Low risk
Matzim LA (Diltiazem Hydrochloride)
GMP Deviation: lot not intended for commercial distribution.
Class I · High risk
Quinacrine Dihydrochloride
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class II · Moderate risk
5% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
10% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
20% Acetyl-L-Cysteine Ophthalmic Solutions
Lack of Processing Controls:
Class II · Moderate risk
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Clonidine HCL PF 750 mcg/mL/Prialt PF
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.