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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 1161–1180 of 18,048 recalls

Class IITerminated

KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 199747, NDC 55758-106-04, UPC 8 9971100128 0.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-440-02, UPC 8 10096 77162 9.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC, New Castle, DE 19720, NDC 55758-109-02, UPC 8 99711 00101 3.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IITerminated

CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-01, UPC 8 10096 77170 4.

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

April 24, 2025 · DrugView details →

Class IIOngoing

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

April 23, 2025 · DrugView details →

Class IIOngoing

Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

April 23, 2025 · DrugView details →

Class IIOngoing

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

April 23, 2025 · DrugView details →

Class IIOngoing

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

BRS Analytical Services, LLC

cGMP deviations and lack of assurance of sterility.

April 23, 2025 · DrugView details →

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 →

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