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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 1241–1260 of 17,683 recalls

Class IIOngoing

TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01

ProRx LLC

Lack of Assurance of Sterility

August 22, 2024 · DrugView details →

Class IIOngoing

SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04

ProRx LLC

Lack of Assurance of Sterility

August 22, 2024 · DrugView details →

Terminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals Inc.

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

August 21, 2024 · DrugView details →

Class IIITerminated

Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1

Elevate Oral Care

LABELING: LABEL MIX-UP.

August 20, 2024 · DrugView details →

Class IIITerminated

Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3

Biocompatibles UK, Ltd.

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

August 15, 2024 · DrugView details →

Class IIOngoing

Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.

Fagron Compounding Services

Lack of Assurance of Sterility

August 15, 2024 · DrugView details →

Class IIOngoing

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

FDC Limited

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

August 12, 2024 · DrugView details →

Class IIOngoing

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).

Direct Rx

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

August 9, 2024 · DrugView details →

Class IIOngoing

Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30

Teva Pharmaceuticals USA, Inc

Superpotent Drug

August 8, 2024 · DrugView details →

Class IIOngoing

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

Preferred Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications - at 18-month Stability testing

August 8, 2024 · DrugView details →

Class IIICompleted

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

August 7, 2024 · DrugView details →

Class IIOngoing

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

August 6, 2024 · DrugView details →

Class IIOngoing

IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

August 6, 2024 · DrugView details →

Class IIOngoing

IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.

Dr. Reddy's Laboratories, Inc.

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

August 6, 2024 · DrugView details →

Class IICompleted

Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.

Zeco LLC

CGMP Deviations: sterile water not used for production

August 5, 2024 · DrugView details →

Class IICompleted

HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210

Zeco LLC

CGMP Deviations: sterile water not used for production

August 5, 2024 · DrugView details →

Class IITerminated

Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

EMPOWER CLINIC SERVICES LLC

Lack of Assurance of Sterility

August 2, 2024 · DrugView details →

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

Baxter Healthcare Corporation

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

August 1, 2024 · DrugView details →

Class IIICompleted

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

Amneal Pharmaceuticals, LLC

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

August 1, 2024 · DrugView details →

Class IIOngoing

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Failed Dissolution Specifications: below specification results

July 31, 2024 · DrugView details →

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