2,661 recalls, newest first
Reason Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin
Reason Failed Impurities/Degradation Specifications:
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Reason Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
Reason Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)