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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 101–120 of 153 recalls

Class IIIOngoing

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02

Organon Llc

Defective Container

May 28, 2024 · DrugView details →

Class IIIOngoing

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04

Organon Llc

Defective Container

May 28, 2024 · DrugView details →

Class IIIOngoing

Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10

Eugia US LLC

Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

May 22, 2024 · DrugView details →

Class IIIOngoing

Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications.

May 16, 2024 · DrugView details →

Class IIIOngoing

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

Rising Pharma Holding, Inc.

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

May 16, 2024 · DrugView details →

Class IIIOngoing

Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications.

May 16, 2024 · DrugView details →

Class IIIOngoing

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.

Bryant Ranch Prepack, Inc.

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

May 10, 2024 · DrugView details →

Class IIIOngoing

Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.

Bryant Ranch Prepack, Inc.

Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

May 10, 2024 · DrugView details →

Class IIIOngoing

Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.

Bryant Ranch Prepack, Inc.

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

May 10, 2024 · DrugView details →

Class IIIOngoing

Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.

Bryant Ranch Prepack, Inc.

Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

May 10, 2024 · DrugView details →

Class IIIOngoing

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.

Bryant Ranch Prepack, Inc.

Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

May 10, 2024 · DrugView details →

Class IIIOngoing

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

May 1, 2024 · DrugView details →

Class IIIOngoing

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Release Testing: Out of specification for particulate matter test.

April 22, 2024 · DrugView details →

Class IIIOngoing

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01

Imprimis NJOF, LLC

Out of specification for assay

April 10, 2024 · DrugView details →

Class IIIOngoing

Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Class IIIOngoing

Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Class IIIOngoing

Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Class IIIOngoing

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Cross Contamination with Other Products

April 9, 2024 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61

Contract Pharmaceuticals Limited Canada

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

February 20, 2024 · DrugView details →

Class IIIOngoing

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60

Contract Pharmaceuticals Limited Canada

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

February 20, 2024 · DrugView details →

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