Class II · Moderate risk
Ohm Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk
Hand Sanitizer
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk
Allopurinol Tablets 100mg
Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk
S2 Racepinephrine Inhalation Solution
Short Fill
Class II · Moderate risk
Class III · Low risk
FentaNYL Citrate 2.5mg/50mL
Short Fill: Underfilled units.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
0.9% Sodium Chloride Injection
CGMP Deviations: potential for trace amounts of product carryover.
Class II · Moderate risk
Allopurinol Tablets USP
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Class II · Moderate risk
Humatrix Microclysmic Gel
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk
Techni-Care Chloroxylenold 3%
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk
Rocuronium Bromide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specification
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix Injection
Lack of Assurance of Sterility