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The Recall Registry is not a government service and does not issue recalls. We gather published recall notices from the U.S. Consumer Product Safety Commission, the U.S. Food and Drug Administration and the National Highway Traffic Safety Administration, and rewrite them in plain language. Always confirm the details with the issuing agency using the link on each recall page.

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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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Highest riskSeriousWorth checkingLabelling issueTap any recall for the hazard and what to do

1,993 recalls · newest first

Food & drug recall · FDANovember 18, 2024Serious

Viatris Inc — Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only

Prescription medicine · Viatris Inc · 19, 549 bottles affected

Superpotent Drug and Subpotent Drug: potency failures obtained

Food & drug recall · FDANovember 15, 2024Serious

Evaric Pharmaceuticals Inc. — Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only

Prescription medicine · Evaric Pharmaceuticals Inc. · 222, 600 bottles affected

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

Food & drug recall · FDANovember 14, 2024Serious

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles

Prescription medicine · Amerisource Health Services LLC · 23,490 bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Food & drug recall · FDANovember 14, 2024Serious

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

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

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

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

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

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Serious

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles

Prescription medicine · Amerisource Health Services LLC · 37,916 bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Food & drug recall · FDANovember 14, 2024Serious

Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle

Prescription medicine · Amerisource Health Services LLC · 8,561 bottles affected

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml)

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 14, 2024Labelling issue

Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 4404 packs affected

Labeling: Not Elsewhere Classified - Wrong NDC number

Food & drug recall · FDANovember 14, 2024Serious

Keystone Industries — Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free

Prescription medicine · Keystone Industries

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and…

Food & drug recall · FDANovember 13, 2024Serious

Brands International Corporation — Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube

Prescription medicine · Brands International Corporation · unknown affected

CGMP Deviations: lack of adequate release testing.

Food & drug recall · FDANovember 11, 2024Serious

American Regent, Inc. — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517

Prescription medicine · American Regent, Inc.

Presence of Particulate Matter: Potential for glass delamination from the vials.

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