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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 1401–1420 of 18,048 recalls

Class IITerminated

phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25

Hikma Injectables USA Inc

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

December 19, 2024 · DrugView details →

Class IITerminated

Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03

Granules Pharmaceuticals Inc.

Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.

December 18, 2024 · DrugView details →

Class IIIOngoing

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

AvKARE

LABELING: LABEL MIX-UP

December 18, 2024 · DrugView details →

Class IOngoing

Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134

Alcon Research LLC

Non-Sterility

December 18, 2024 · DrugView details →

Class IIOngoing

medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India

Eugia US LLC

CGMP Deviations

December 18, 2024 · DrugView details →

Class IIIOngoing

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15

AvKARE

LABELING: LABEL MIX-UP

December 18, 2024 · DrugView details →

Class IITerminated

glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11

Amerisource Health Services LLC

Failed Dissolution Specifications:

December 17, 2024 · DrugView details →

Class IIOngoing

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

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

December 16, 2024 · DrugView details →

Class IOngoing

FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7

SHOPPERS- PLAZA

Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide

December 16, 2024 · DrugView details →

Class IIITerminated

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

SOMERSET THERAPEUTICS LLC

Failed Impurities/Degradation Specifications

December 16, 2024 · DrugView details →

Class IIOngoing

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

Amerisource Health Services LLC

Presence of Foreign Tablets/Capsules

December 13, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Akron Pharma, Inc.

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

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.

Akron Pharma, Inc.

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

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.

Akron Pharma, Inc.

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

December 12, 2024 · DrugView details →

Class IOngoing

Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.

Buy-Herbal

Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine

December 12, 2024 · DrugView details →

Class IIOngoing

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

Ascend Laboratories, LLC

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

December 12, 2024 · DrugView details →

Class IIOngoing

Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60

Ascend Laboratories, LLC

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

December 12, 2024 · DrugView details →

Class IIIOngoing

Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .

Akron Pharma, Inc.

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

December 12, 2024 · DrugView details →

Class IIIOngoing

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

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, 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 →

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