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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 341–360 of 721 recalls

Class IIOngoing

Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.

Shimoga Chemicals

cGMP deviations

May 19, 2026 · DrugView details →

Class IIIOngoing

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

Eugia US LLC

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

May 18, 2026 · DrugView details →

Class IIOngoing

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.

IntegraDose Compounding Services LLC

Subpotent Drug

May 18, 2026 · DrugView details →

Class IIIOngoing

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

AbbVie Inc.

Failed Stability Specifications

May 18, 2026 · DrugView details →

Class IIOngoing

PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO

PReye LLC

Lack of Assurance of Sterility

May 18, 2026 · DrugView details →

Class IIOngoing

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.

PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

May 15, 2026 · DrugView details →

Class IIOngoing

VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.

PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

May 15, 2026 · DrugView details →

Class IIOngoing

VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.

PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

May 15, 2026 · DrugView details →

Class IIOngoing

VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.

PAI Holdings LLC

Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

May 15, 2026 · DrugView details →

Class IIIOngoing

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

May 14, 2026 · DrugView details →

Class IIIOngoing

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Fresenius Kabi USA, LLC

Failed Impurities/Degradations Specifications

May 14, 2026 · DrugView details →

Class IIOngoing

Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.

Asclemed USA Inc.

CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

May 14, 2026 · DrugView details →

Class IIOngoing

Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.

Spectra Medical Devices, Llc

Lack of Assurance of Sterility

May 12, 2026 · DrugView details →

Class IIOngoing

fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.

IntegraDose Compounding Services LLC

Subpotent Drug

May 12, 2026 · DrugView details →

DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Particulate matter: Particulate matter identified as glass.

May 12, 2026 · DrugView details →

Class IIOngoing

Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20

ANI Pharmaceuticals, Inc.

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

May 12, 2026 · DrugView details →

Class IIOngoing

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Haleon US Holdings LLC

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

May 11, 2026 · DrugView details →

Class IIOngoing

cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.

UCB Biosciences Inc.

Lack of Assurance of Sterility

May 8, 2026 · DrugView details →

Class IIOngoing

Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.

Ascend Laboratories, LLC

Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

May 5, 2026 · DrugView details →

Class IIIOngoing

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Sagent Pharmaceuticals

Failed Impurities/Degradation Specifications

May 4, 2026 · DrugView details →

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