Class I · High risk
Magnesium Sulfate Inj.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
FDA drug recalls in 2016
Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,199 recalls, newest first.
Class II · Moderate risk
PerioRx (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
Chlorhexidine gluconate
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
ORIS (chlorhexidine gluconate)
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Class II · Moderate risk
Renovo Patch
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Ciprofloxacin Ophthalmic Solution
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Class III · Low risk
Quelicin (Succinylcholine Chloride)
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 0 (PGE 20 mcg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 1
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 9
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Superpotent Drug: one ingredient was found to be above assay specification.
Class III · Low risk
Ceftriaxone Sodium
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.