Class III · Low risk
Fluconazole Injection
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class III · Low risk
Diazepam Rectal Gel
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Subpotent Drug
Class II · Moderate risk
Admelog Solostar
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk
alba BOTANICA sport mineral sunscreen
Incorrect Product Formulation: wrong sunscreen product in the package.
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class II · Moderate risk
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Class II · Moderate risk
Monsel's Solution
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Class I · High risk
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial
Presence of Particulate Matter: identified as glass and silicone material
Class II · Moderate risk
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class I · High risk
Neostigmine Methylsulfate Injection Solution
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class I · High risk
Neostigmine Methylsulfate Injection Solution
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class II · Moderate risk
Daptomycin for Injection
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk
Nitrofurantoin Oral Suspension USP
Subpotent Drug and Failed Content Uniformity.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk
Enalapril Maleate
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class I · High risk
Blissful Remedies Kratom+CBD CBD infused Maeng Da
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I · High risk
Blissful Remedies Gold Series Ultra Enhanced Indo
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I · High risk
Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I · High risk
Blissful Remedies
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I · High risk
Blissful Remedies Red Maeng Da
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.