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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 81–100 of 153 recalls

Class IIIOngoing

Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

Akron Pharma, Inc.

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

December 12, 2024 · DrugView details →

Class IIIOngoing

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications

November 22, 2024 · DrugView details →

Class IIIOngoing

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets

Zydus Pharmaceuticals (USA) Inc

Labeling: Not Elsewhere Classified - Wrong NDC number

November 14, 2024 · DrugView details →

Class IIIOngoing

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specifications

October 29, 2024 · DrugView details →

Class IIIOngoing

Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Defective Container: Firm received complaints of broken tube at the seal.

September 30, 2024 · DrugView details →

Class IIIOngoing

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

Denison Pharmaceuticals, LLC

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

September 25, 2024 · DrugView details →

Class IIIOngoing

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

Denison Pharmaceuticals, LLC

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

September 25, 2024 · DrugView details →

Class IIIOngoing

AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01

Rubicon Research Private Limited

Discoloration

August 24, 2024 · DrugView details →

Class IIIOngoing

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,

Zydus Pharmaceuticals (USA) Inc

Cross contamination with other products.

July 2, 2024 · DrugView details →

Class IIIOngoing

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.

Zydus Pharmaceuticals (USA) Inc

Cross contamination with other products.

July 2, 2024 · DrugView details →

Class IIIOngoing

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

Dr. Reddy's Laboratories, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

June 26, 2024 · DrugView details →

Class IIIOngoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0

GLOBAL WIDGET LLC

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

June 25, 2024 · DrugView details →

Class IIIOngoing

Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5

GLOBAL WIDGET LLC

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

June 25, 2024 · DrugView details →

Class IIIOngoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7

GLOBAL WIDGET LLC

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

June 25, 2024 · DrugView details →

Class IIIOngoing

Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2

GLOBAL WIDGET LLC

Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.

June 25, 2024 · DrugView details →

Class IIIOngoing

Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

Rising Pharma Holding, Inc.

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

June 24, 2024 · DrugView details →

Class IIIOngoing

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

Neilmed Pharmaceuticals Inc

Sub-potent Drug

June 24, 2024 · DrugView details →

Class IIIOngoing

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications: Related Substances

June 4, 2024 · DrugView details →

Class IIIOngoing

Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03

Organon Llc

Defective Container

May 28, 2024 · DrugView details →

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