Class II · Moderate risk
WP Thyroid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Nature-Throid
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Class II · Moderate risk
Protz real protection Antibacterial Hand Sanitizer
Lack of CGMPs:
Class II · Moderate risk
Class II · Moderate risk
Cephalexin for Oral Suspension
Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets USP
CGMP Deviations
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Zanilast+ Gel Antiseptic Hand Sanitizer
GMP Deviations: Potential to contain 1-propanol.
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class II · Moderate risk
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz
cGMP Deviations
Class I · High risk
Goldenseal Root Powder Organic
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class I · High risk
Tranexamic Acid Injection
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.