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 drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
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 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.
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
Class III · Low risk
col-rite (docusate sodium)
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Class III · Low risk
Telmisartan Tablets
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Minocycline Hydrochloride Capsules USP
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
Class III · Low risk
Scrub-Stat 4
Subpotent drug
Class III · Low risk
sulfur8 medicated LIGHT FORMULA
Subpotent Drug: failed at the 3 and 6 month stability time points.
Class III · Low risk
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle
Labeling: Label Mix-Up
Class III · Low risk
Oxygen
CGMP Deviations: Cylinders filled using out of date gauges.
Class III · Low risk
Triamcinolone Diacetate Injectable Suspension
Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond " date or BUD (Before Use Date) that may be longer than intended.
Class III · Low risk
Normosol-M and 5% Dextrose
Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
Class III · Low risk
Clonazepam Tablets
Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
Class III · Low risk
Atorvastatin Calcium 80 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 40 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 20 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium 10 mg
Failed Impurities/Degradation Specifications
Class III · Low risk
Duloxetine Delayed-Release Capsules
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.