Class II · Moderate risk
Doxycycline Hyclate USP
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
FDA Drug Recalls
173 recalls, newest first
Class II · Moderate risk
Saphris 10 mg
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Amitriptyline HCL Tablets
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class II · Moderate risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class I · High risk
Phenobarbital Tablets USP
Labeling: Label Mixup; potentially mislabeled
Class I · High risk
Phenobarbital Tablets USP
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Class III · Low risk
Zinc Oxide Paste 25%
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class II · Moderate risk
Fentanyl Citrate
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class II · Moderate risk
Fentanyl Citrate
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class II · Moderate risk
Refresh Tears
Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information and does not contain the Drug Facts Panel.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class II · Moderate risk
Desonide Ointment
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Class II · Moderate risk
Fentanyl Citrate and Bupivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Fentanyl Citrate with Ropivacaine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Sodium Citrate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Sodium Phosphate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Potassium Phosphate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Magnesium Sulfate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Cardioplegic Solution Maintenance all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Dexmedetomidine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Dexamethasone Sodium Phosphate all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Bumetadine all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
Ondansetron HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.