Class III · Low risk
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Methylprednisolone Acetate Injectable Suspension
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Fentanyl Buccal Tablets CII
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Gabapentin Tablets
Product mixup: one foreign tablet found in product.
Class III · Low risk
Lidocaine Patch 5%
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Class III · Low risk
Avicel DG
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Subpotent Drug: Out of specification results for low potency was obtained.
Class III · Low risk
Norepinephrine Bitartrate Injection
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III · Low risk
Dodex Injectable Cyanocobalamin Injection
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class III · Low risk
Bevacizumab 2.5 mg/0.1 mL
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III · Low risk
Montelukast Sodium Oral Granules USP
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class III · Low risk
MEKTOVI (binimetinib)
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class III · Low risk
Colchicine Tablets
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class III · Low risk
Fentanyl 1
Subpotent Drug
Class III · Low risk
Evamist (estradiol transdermal spray)
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.