Drug Recalls
RSS ↗2,051 drug recalls from federal enforcement feeds.
Showing 1,051–1,100 of 2,051
- Class II
Drug Recall · May 28, 2025
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- Class II
Drug Recall · May 27, 2025
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDCCGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Class II
Drug Recall · May 27, 2025
Fresenius Medical Care Holdings, Inc.
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10Lack of Assurance of Sterility
- Class II
Drug Recall · May 27, 2025
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 136CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Class II
Drug Recall · May 23, 2025
Consumer Product Partners, LLC
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
- Class II
Drug Recall · May 23, 2025
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2Presence of foreign tablets/capsules.
- Class II
Drug Recall · May 23, 2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDCFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Class II
Drug Recall · May 23, 2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDCFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Class II
Drug Recall · May 22, 2025
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class I
Drug Recall · May 21, 2025
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, aLack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class I
Drug Recall · May 21, 2025
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, SLack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class II
Drug Recall · May 21, 2025
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112Lack of Assurance of Sterility
- Class III
Drug Recall · May 19, 2025
Glenmark Pharmaceuticals Inc., USA
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: GlFailed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
- Class II
Drug Recall · May 15, 2025
Glenmark Pharmaceuticals Inc., USA
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: GlOOS results reported for the Dissolution (by UV) test.
- Class II
Drug Recall · May 15, 2025
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, FlamLack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- Class II
Drug Recall · May 14, 2025
AsttraZeneca Pharmaceuticals LP
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, MDefective delivery system
- Class II
Drug Recall · May 13, 2025
Zydus Pharmaceuticals (USA) Inc
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 PhFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Class II
Drug Recall · May 13, 2025
Zydus Pharmaceuticals (USA) Inc
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 PhFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Class II
Drug Recall · May 13, 2025
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- Class II
Drug Recall · May 9, 2025
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.cGMP deviations
- Class II
Drug Recall · May 9, 2025
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15Failed Dissolution Specifications
- Class II
Drug Recall · May 9, 2025
Alembic Pharmaceuticals Limited
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic PharmaceuticalPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
- Class II
Drug Recall · May 9, 2025
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.cGMP deviations
- Class II
Drug Recall · May 7, 2025
Alembic Pharmaceuticals Limited
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, GujaFailed Impurities/Degradation Specifications
- Class I
Drug Recall · May 6, 2025
EnShiShiXiangNiShangMaoYouXianGongSi
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8NMarketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
- Class II
Drug Recall · May 2, 2025
Empower Clinic Services, LLC dba Empower Pharmacy
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) 562-85Lack of Assurance of Sterility
- Class II
Drug Recall · April 28, 2025
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.CGMP Deviations
- Class II
Drug Recall · April 28, 2025
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 #21Presence of Particulate Matter: Glass particles were found in pellet vials.
- Class II
Drug Recall · April 28, 2025
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 802Presence of Particulate Matter: Glass particles were found in pellet vials.
- Class II
Drug Recall · April 28, 2025
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 #21Presence of Particulate Matter: Glass particles were found in pellet vials.
- Class II
Drug Recall · April 28, 2025
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar DriPresence of Particulate Matter: Glass particles were found in pellet vials.
- Class II
Drug Recall · April 28, 2025
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 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 #21Presence of Particulate Matter: Glass particles were found in pellet vials.
- Class II
Drug Recall · April 25, 2025
Mckesson Medical-Surgical Inc. Corporate Office
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter HealthcSevere thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
- Class II
Drug Recall · April 25, 2025
Mckesson Medical-Surgical Inc. Corporate Office
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.