Should I stop taking a recalled medicine?

Check the lot number on your package against the notice first; most recalls cover specific lots. If yours is included, ask your pharmacist about a replacement before stopping a prescribed medicine, because stopping some drugs abruptly is itself a risk.

Does a medical device recall mean I have to stop using the device?

Not always. The FDA notes that a device recall can mean a correction, a software update or new instructions rather than a return. The manufacturer’s letter, sent through your clinic or supplier, says what to do.

Why do some recalls on this list involve products sold as supplements?

Because the FDA recalls supplements that contain undeclared drug ingredients or are marketed without approval. Those are treated as Class I when the hidden ingredient could cause serious harm.

Recalls & Safety · Tracker

Drug and medical device recalls

The most serious drug, supplement and medical device recalls the FDA is monitoring, from its weekly Enforcement Report, with the product, the firm and the reason.

By Mirza Seraj Baig, Founder and EditorPublished September 4, 2026

Last verified Sep 4, 2026, 9:44 PM EDT · refreshed weekly

A Class I recall is one where the FDA finds a reasonable probability that the product could cause serious harm or death. For drugs that usually means contamination, particulate matter in an injectable, an undeclared drug ingredient in a product sold as a supplement, or a product marketed without approval. For devices it means a failure that could injure a patient. The rows below are the Class I drug and device recalls in the most recent Enforcement Reports.

A device recall does not always mean the device must be stopped or returned; the manufacturer’s letter to clinicians and patients says what to do, and the FDA’s guidance is to follow it. How FDA recall classes work explains the classes.

Swipe sideways to see every column.

Drug and medical device recalls
Report date	Type	Product	Recalling firm	Reason	Source
August 19, 2026	Drug	Kian Pee Wan Capsules, 30-count bottles	Buy-Herbal	Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.	fda.gov
August 19, 2026	Drug	Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Ad	Victory Medical Center Pharmacy	Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.	fda.gov
August 19, 2026	Drug	Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile So	Liebel-Flarsheim Company LLC	Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.	fda.gov
August 12, 2026	Drug	Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont	Sunny Pharmtech Inc.	Presence of Particulate Matter; identified as stainless steel	fda.gov
August 12, 2026	Drug	Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont	Sunny Pharmtech Inc.	Presence of Particulate Matter; identified as stainless steel	fda.gov
July 29, 2026	Drug	Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharm	JB Chemicals and Pharmaceuticals Ltd	Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP	fda.gov
August 19, 2026	Device	Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10	Spectra Medical Devices, Llc	Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be expo	fda.gov
August 19, 2026	Device	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets	Baxter Healthcare Corporation	Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open po	fda.gov
August 12, 2026	Device	Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15	AVID Medical, Inc.	Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid	fda.gov
August 12, 2026	Device	Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. CARDIAC CATH PACK EAMC1000-05	AVID Medical, Inc.	Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid	fda.gov
August 12, 2026	Device	INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC231	Boston Scientific Neuromodulation Corporation	Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which ma	fda.gov
August 12, 2026	Device	Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. HEART CATH, SELF REGIONAL SELF131-05	AVID Medical, Inc.	Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid	fda.gov

Class I drug and device recalls from the FDA Enforcement Report as retrieved on September 4, 2026 through the openFDA enforcement datasets. Many device recalls are corrections carried out in hospitals rather than product returns; the firm’s notice states the action.Download CSV

What to do

If you have a listed drug, check the lot number on the package against the FDA notice and ask your pharmacist about a replacement before stopping a prescribed medicine. Official link
If you use a listed device, contact the clinic or supplier that provided it; the manufacturer’s instructions are sent through them. Official link

FactFiled is an independent news publisher. It is not the agency, company or claims administrator named on this page, does not process claims or payments, and never asks readers for account details.

Questions readers ask

Should I stop taking a recalled medicine?: Check the lot number on your package against the notice first; most recalls cover specific lots. If yours is included, ask your pharmacist about a replacement before stopping a prescribed medicine, because stopping some drugs abruptly is itself a risk.
Does a medical device recall mean I have to stop using the device?: Not always. The FDA notes that a device recall can mean a correction, a software update or new instructions rather than a return. The manufacturer’s letter, sent through your clinic or supplier, says what to do.
Why do some recalls on this list involve products sold as supplements?: Because the FDA recalls supplements that contain undeclared drug ingredients or are marketed without approval. Those are treated as Class I when the hidden ingredient could cause serious harm.

Background: How FDA recall classes work

Mentioned:Food and Drug Administration

How we reported this

Built from the documents in the Source Card. Opened with the Class I drug and device recalls in the FDA Enforcement Reports of July and August 2026, retrieved September 4, 2026.

Written by Mirza Seraj Baig · Checked against the documents in the source card (editorial standards).

Updates

September 4, 2026Opened with the Class I drug and device recalls in the FDA Enforcement Reports of July and August 2026, retrieved September 4, 2026.