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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 21–40 of 1,000 recalls

Class IIOngoing

Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl. oz. (15 mL) bottles; a) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25114 4; b) Good Sense Sterile Eye Drops, Distributed By: Geiss, Destin & Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-121-01; c) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43746 7; d) QC-Quality Choice, Sterile Eye drops Irritation Relief, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-190-14; e) TopCare health TM, DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 03640 6.

K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

September 11, 2026 · DrugView details →
Class IIOngoing

Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.

K.C. Pharmaceuticals, Inc.

Lack of Assurance of Sterility

September 11, 2026 · DrugView details →
Class IIOngoing

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland

Carolina Infusion, LLC

Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

September 10, 2026 · DrugView details →
Class IIOngoing

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

Amneal Pharmaceuticals, LLC

Defective Container; packets were found to be either empty or partially full.

September 8, 2026 · DrugView details →
Class IIOngoing

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

Par Health USA, LLC

Crystallization

September 8, 2026 · DrugView details →
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