July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 801
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dex
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood,
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) recalls Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Engl
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb,
Hazard: Presence of foreign tablets/capsules.
June 25, 2025DrugsFDA
Umary-USA.com recalls UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UP
Hazard: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
June 25, 2025DrugsFDA
Umary-USA.com recalls UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UP
Hazard: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
June 25, 2025DrugsFDA
Eugia US LLC recalls Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India fo
Hazard: Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
June 25, 2025DrugsFDA
Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,
Hazard: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
June 18, 2025DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza,
Hazard: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
June 18, 2025DrugsFDA
Amneal Pharmaceuticals, LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b)
Hazard: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
June 18, 2025DrugsFDA
Macleods Pharmaceuticals Ltd recalls Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc.
Hazard: Presence of a foreign substance: black hair found embedded in tablet.
June 18, 2025DrugsFDA
Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories
Hazard: Failed 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.
June 18, 2025DrugsFDA
Ascend Laboratories, LLC recalls Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories
Hazard: Failed 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.
June 18, 2025DrugsFDA
SAINI TRADE INC recalls Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Hazard: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
June 18, 2025DrugsFDA
SAINI TRADE INC recalls ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, U
Hazard: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
June 18, 2025DrugsFDA
SAINI TRADE INC recalls ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Hazard: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
June 18, 2025DrugsFDA
SAINI TRADE INC recalls MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, U
Hazard: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
June 18, 2025DrugsFDA
SAINI TRADE INC recalls Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, U
Hazard: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
June 18, 2025DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd.,
Hazard: Failed 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.
June 18, 2025DrugsFDA
AvKARE recalls Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pul
Hazard: Failed Dissolution Specifications
June 18, 2025DrugsFDA
AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 3847
Hazard: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
June 18, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Div
Hazard: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
June 11, 2025DrugsFDA
Consumer Product Partners, LLC recalls Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industrie
Hazard: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
June 11, 2025DrugsFDA
Apotex Corp. recalls Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Hazard: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
June 11, 2025DrugsFDA
Torrent Pharma Inc. recalls Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-38
Hazard: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
June 11, 2025DrugsFDA
Torrent Pharma Inc. recalls Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721
Hazard: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.