Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx…
Reason Subpotent and Superpotent Drug
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx…
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx…
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx…
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets…
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct…
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC…
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Terminated
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for…
Reason Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Class II · Moderate risk Ongoing
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Reason cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and…
Class II · Moderate risk Terminated
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY…
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…