Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Amitiza (lubiprostone)
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class II · Moderate risk
Amitiza (lubiprostone)
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Class I · High risk
Promacta (eltrombopag)
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Class III · Low risk
QUIK-CARE Aerosol Foam Hand Sanitizer
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Class II · Moderate risk
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
Anastrozole Tablets
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
MethylPREDNISolone Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.5 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochoride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole DihydrochlorideTablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Anastrozole Tablets
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.