Class II · Moderate risk
Azithromycin Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine Besylate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrocrystals Capsules
Failed Dissolution Specification; 6 month time point
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk
Chlordiazepoxide HCl/Clidinium Bromide capsules
Failed Impurities/Degradation Specifications
Class III · Low risk
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Nifedipine Extended-Release Tablets
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Class II · Moderate risk
Well at Walgreens Regular Strength Antacid Liquid
Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Mucinex Fast Max DM Max
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Severe Congestion & Cough
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast-Max Cold & Sinus
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Night Time Cold & Flu
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Cold
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class III · Low risk
Cetirizine HCl Chewable Tablet
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class III · Low risk
Flurandrenolide Tape
Subpotent Drug: Flurandrenolide is subpotent.
Class I · High risk
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
Class I · High risk
HEPARIN Sodium Injection USP 25
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.