FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing Apr 12, 2021
Reason Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified…
Class II · Moderate risk Ongoing Apr 9, 2021
Reason Failed Impurities/Degradation Specifications:
Class I · High risk Ongoing Apr 8, 2021
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class I · High risk Ongoing Apr 8, 2021
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Class II · Moderate risk Ongoing Apr 6, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Ongoing Apr 6, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Ongoing Apr 6, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk Ongoing Mar 31, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing Mar 31, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing Mar 31, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing Mar 31, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing Mar 31, 2021
Reason Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Class II · Moderate risk Ongoing Mar 30, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing Mar 30, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I · High risk Ongoing Mar 29, 2021
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an…
Class I · High risk Ongoing Mar 29, 2021
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making…
Class I · High risk Ongoing Mar 29, 2021
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…
Class I · High risk Ongoing Mar 29, 2021
Reason Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them…
Class II · Moderate risk Ongoing Mar 25, 2021
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class III · Low risk Ongoing Mar 19, 2021
Reason Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Class II · Moderate risk Ongoing Mar 10, 2021
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk Ongoing Mar 10, 2021
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk Ongoing Mar 10, 2021
Reason CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class I · High risk Ongoing Feb 2, 2021
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…
Class I · High risk Ongoing Feb 2, 2021
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…