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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,102 recalls · newest first

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 5 affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 16 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 28 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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-Argini

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 102 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 16 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 826 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 64 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 242 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 21, 2025Serious

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 80112

Prescription medicine · Thrive Health and Wellness, LLC, dba… · 4 syringes affected

Lack of Assurance of Sterility

Food & drug recall · FDAMay 19, 2025Labelling issue

Glenmark Pharmaceuticals Inc., USA — Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 6,759 Con - 90 bottle pack affected

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…

Food & drug recall · FDAMay 15, 2025Serious

CareFusion 213, LLC — 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 Us

Prescription medicine · CareFusion 213, LLC · 385,200 applicators affected

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

Food & drug recall · FDAMay 15, 2025Serious

Glenmark Pharmaceuticals Inc., USA — Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 8,520 100-count bottles affected

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

Food & drug recall · FDAMay 15, 2025Serious

Amerisource Health Services LLC — Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only

Prescription medicine · Amerisource Health Services LLC · 21 cartons affected

cGMP deviations

Food & drug recall · FDAMay 14, 2025Serious

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, Manufac

Prescription medicine · AsttraZeneca Pharmaceuticals LP · a) 807,837 canisters; b) 235,698 canisters affected

Defective delivery system

Food & drug recall · FDAMay 13, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 30,674 30 sachets/carton affected

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…

Food & drug recall · FDAMay 13, 2025Serious

Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only

Prescription medicine · Zydus Pharmaceuticals (USA) Inc · 22,152 30 sachets/carton affected

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during…

Food & drug recall · FDAMay 9, 2025Serious

KVK Tech, Inc. — 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.

Prescription medicine · KVK Tech, Inc. · 9107 bottles affected

cGMP deviations

Food & drug recall · FDAMay 9, 2025Serious

AvKARE — Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only

Prescription medicine · AvKARE · 962 cartons affected

Failed Dissolution Specifications

Food & drug recall · FDAMay 9, 2025Serious

KVK Tech, Inc. — 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.

Prescription medicine · KVK Tech, Inc. · 9680 bottles affected

cGMP deviations

Food & drug recall · FDAMay 7, 2025Serious

Alembic Pharmaceuticals Limited — Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile

Prescription medicine · Alembic Pharmaceuticals Limited · N/A affected

Failed Impurities/Degradation Specifications