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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 961–980 of 1,000 recalls

Class IIOngoing

Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Lack of Assurance of Sterility

May 21, 2025 · DrugView details →

Class IIOngoing

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).

Amerisource Health Services LLC

cGMP deviations

May 15, 2025 · DrugView details →

Class IIOngoing

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

Glenmark Pharmaceuticals Inc., USA

OOS results reported for the Dissolution (by UV) test.

May 15, 2025 · DrugView details →

Class IIOngoing

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

CareFusion 213, LLC

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

May 15, 2025 · DrugView details →

Class IIOngoing

Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .

AsttraZeneca Pharmaceuticals LP

Defective delivery system

May 14, 2025 · DrugView details →

Class IIOngoing

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

May 13, 2025 · DrugView details →

Class IIOngoing

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

Zydus Pharmaceuticals (USA) Inc

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

May 13, 2025 · DrugView details →

Class IIOngoing

Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15

AvKARE

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

May 13, 2025 · DrugView details →

Class IIOngoing

Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

AvKARE

Failed Dissolution Specifications

May 9, 2025 · DrugView details →

Class IIOngoing

Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.

KVK Tech, Inc.

cGMP deviations

May 9, 2025 · DrugView details →

Class IIOngoing

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71

Alembic Pharmaceuticals Limited

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

May 9, 2025 · DrugView details →

Class IIOngoing

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.

KVK Tech, Inc.

cGMP deviations

May 9, 2025 · DrugView details →

Class IIOngoing

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

Alembic Pharmaceuticals Limited

Failed Impurities/Degradation Specifications

May 7, 2025 · DrugView details →

Class IIOngoing

Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.

Empower Clinic Services, LLC dba Empower Pharmacy

Lack of Assurance of Sterility

May 2, 2025 · DrugView details →

Class IIOngoing

temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.

Siddha Flower Essences, LLC.

CGMP Deviations

April 28, 2025 · DrugView details →

Class IIOngoing

TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01

BSO LLC

Presence of Particulate Matter: Glass particles were found in pellet vials.

April 28, 2025 · DrugView details →

Class IIOngoing

TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01

BSO LLC

Presence of Particulate Matter: Glass particles were found in pellet vials.

April 28, 2025 · DrugView details →

Class IIOngoing

TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01

BSO LLC

Presence of Particulate Matter: Glass particles were found in pellet vials.

April 28, 2025 · DrugView details →

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