Class II · Moderate risk
Ginseng Kianpi Pil
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
FDA Drug Recalls
24 recalls · Class II, newest first
Class II · Moderate risk
MAYHEM capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Class II · Moderate risk
ZEE Aspirin 325mg - 24 tablets in single dose packets
Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.
Class II · Moderate risk
Doctor's Best Red Yeast Rice 1200
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG 125U/Tab Tablet Tritu
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Diphenhydramine
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Mometasone 0.6 mg /60 mL Irrigation solution
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Tev-Tropin
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/ml
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL CR (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL CR (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 37.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 25 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
PAXIL (Paroxetine HCL)
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Paroxetine HCL Controlled-Release Tablets 12.5 mg
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class II · Moderate risk
Fluoxetine Capsules
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.