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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 21–40 of 623 recalls

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 →

Class IIOngoing

Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.

Pfizer

Lack of Assurance of Sterility

September 4, 2026 · DrugView details →

Class IIOngoing

fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.

OurPharma LLC

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

September 3, 2026 · DrugView details →

Class IIOngoing

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

Inventia Healthcare Limited

Failed Dissolution Specifications

September 3, 2026 · DrugView details →

Class IIOngoing

Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.

SV Labs Toronto Corporation

Microbial contamination of topical product.

September 1, 2026 · DrugView details →

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