Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED Hand Sanitizer Gel
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
Imperia Elita Vitaccino Coffee
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Class II · Moderate risk
Preferred Pharmaceuticals Inc.
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class II · Moderate risk
Cephalexin for Oral Suspension
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
Class II · Moderate risk
Flurandrenolide Ointment USP
Failed Impurities/Degradation Specifications:
Class II · Moderate risk
Triple SupremeZen Plus 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
PremierZen Black 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Class II · Moderate risk
Imperial Platinum 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Burro en Primavera
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Extreme 3000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Imperial Gold 2000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Guanfacine Extended-Release Tablets 2 mg
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
Class II · Moderate risk
Triple SupremeZen Gold 3500
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
PremierZen Platinum 5000
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk
Imperial Extreme 2000 Capsules
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk
aulief (Organic Camphor 3.00% Organic Menthol 5.00%)
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
China-Gel White
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
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
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
Spironolactone Tablets
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level