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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 701–720 of 1,000 recalls

Class IIOngoing

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

April 23, 2025 · DrugView details →

Class IIOngoing

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

RemedyRePack Inc.

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

April 22, 2025 · DrugView details →

Class IIOngoing

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

Eugia US LLC

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

April 21, 2025 · DrugView details →

Class IIOngoing

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations; potential temperature excursions due to transit delays

April 21, 2025 · DrugView details →

Class IIOngoing

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

Eugia US LLC

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

April 21, 2025 · DrugView details →

Class IIOngoing

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations; potential temperature excursions due to transit delays

April 21, 2025 · DrugView details →

Class IIOngoing

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations; potential temperature excursions due to transit delays

April 21, 2025 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.

FDC Limited

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

April 18, 2025 · DrugView details →

Class IIOngoing

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

American Regent, Inc.

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

April 18, 2025 · DrugView details →

Class IIOngoing

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

American Regent, Inc.

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

April 18, 2025 · DrugView details →

Class IIOngoing

Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.

Preferred Pharmaceuticals, Inc.

cGMP Deviations

April 18, 2025 · DrugView details →

Class IITerminated

Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-406-30

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IIOngoing

Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave# 1507, CA 90501, NDC 71300-6564-1 (box), 71300-6564-3 (vial).

Nubratori, Inc

Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025.

April 15, 2025 · DrugView details →

Class IITerminated

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IITerminated

DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IIOngoing

FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25

Apollo Care, LLC

Lack of Assurance of Sterility

April 15, 2025 · DrugView details →

Class IITerminated

Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle, Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-405-99

Pharmadel, LLC

cGMP deviations

April 15, 2025 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10

Breckenridge Pharmaceutical, Inc

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

April 14, 2025 · DrugView details →

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