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FDA Drug Recalls

411 recalls · Class II, newest first

Class II · Moderate risk Ongoing Nov 19, 2024

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

Rising Pharma Holding, Inc. NDC 57237-019-30 D-0107-2025

Class II · Moderate risk Ongoing Nov 19, 2024

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

Rising Pharma Holding, Inc. NDC 57237-018-30 D-0106-2025

Class II · Moderate risk Ongoing Nov 19, 2024

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

Rising Pharma Holding, Inc. NDC 57237-017-60 D-0105-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1811-77 D-0128-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1809-77 D-0127-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1807-77 D-0126-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1805-77 D-0125-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1803-77 D-0124-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1800-77 D-0123-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1819-77 D-0122-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1817-77 D-0121-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1815-77 D-0120-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1823-77 D-0119-2025

Class II · Moderate risk Ongoing Nov 18, 2024

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

Viatris Inc NDC 0378-1813-77 D-0118-2025

Class II · Moderate risk Terminated Nov 15, 2024

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.

Evaric Pharmaceuticals Inc. NDC 68645-610-90 D-0061-2025

Class II · Moderate risk Ongoing Nov 14, 2024

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…

Mxbbb D-0166-2025

Class II · Moderate risk Terminated Nov 14, 2024

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…

Keystone Industries D-0148-2025

Class II · Moderate risk Terminated Nov 14, 2024

Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.

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…

Keystone Industries D-0147-2025

Class II · Moderate risk Terminated Nov 14, 2024

Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental…

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…

Keystone Industries D-0146-2025

Class II · Moderate risk Terminated Nov 14, 2024

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free…

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…

Keystone Industries NDC 67239-0219-1 D-0145-2025

Class II · Moderate risk Terminated Nov 14, 2024

Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for…

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…

Keystone Industries D-0144-2025

Class II · Moderate risk Terminated Nov 14, 2024

Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma…

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…

Keystone Industries D-0143-2025

Class II · Moderate risk Terminated Nov 14, 2024

Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.

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…

Keystone Industries NDC 69634-021-30 D-0142-2025

Class II · Moderate risk Terminated Nov 14, 2024

Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson…

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…

Keystone Industries NDC 50227-1002-3 D-0141-2025

Class II · Moderate risk Terminated Nov 14, 2024

Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City…

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…

Keystone Industries D-0140-2025