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American Regent's Papaverine HCl Injection (60 mg/2 mL) has been found to contain particulate matter identified as glass and/or paraformaldehyde. The contamination affects one lot (25202, expiring 11/30/2026) distributed nationwide. This is a prescription injectable medication used to treat certain circulatory conditions.

Serious·FDA·Aug 26, 202612 products

Some Fresenius Kabi morphine sulfate prefilled syringes are labeled as morphine 2 mg/mL but actually contain Dilaudid (hydromorphone) 0.5 mg/0.5 mL. This labeling error could lead to patients receiving the wrong medication and dose. The affected lot is 6402820 with an expiration date of 12/2028.

Serious·FDA·Aug 26, 2026

Optimal Balance Pharmacy identified elevated bacterial endotoxin levels in one lot of compounded glutathione 200 mg/mL multi-dose vials during testing. Endotoxins can cause fevers, low blood pressure, severe allergic reactions, and in serious cases, death. The pharmacy has already received reports of adverse events including fever, chills, severe headache, nausea, vomiting, and allergic-like reactions.

Serious·FDA·Aug 19, 2026·Optimal Balance Pharmacy

Baxter Healthcare Corporation is recalling one lot of Cefazolin in Dextrose injection due to the presence of particulate matter in the solution. The affected product is a frozen premix infusion bag used for intravenous antibiotic treatment. This is a Class I recall, the most serious classification.

Serious·FDA·Aug 19, 2026

Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (ioversol injection 74%, 350 mg/mL) due to the presence of particulate matter—including plastic, stainless steel, and glass—found in affected vials. The contamination affects lot #25ZF3670 with an expiration date of May 31, 2027, distributed nationwide in the US and Mexico.

Serious·FDA·Aug 19, 2026·Liebel-Flarsheim

Victory Medical Center Pharmacy's Glutathione injectable solution (200 mg/mL) failed sterility testing and was found to contain elevated bacterial endotoxin levels, which are out of acceptable limits. The affected product was distributed nationwide in specific lots with expiration dates through August 2026.

Serious·FDA·Aug 19, 2026·Victory Medical Center Pharmacy

Cyclophosphamide for Injection, USP (1 gram/vial) manufactured by Sunny Pharmtech Inc. for Long Grove Pharmaceuticals may contain stainless steel particulate matter. The contamination was identified in two specific lots before distribution was completed.

Serious·FDA·Aug 12, 2026·Sunny Pharmtech2 products

Schwarzkopf Professional Osis Grip extra strong mousse in 6.76 fl. oz aluminum cans may leak under pressure due to a packaging defect, creating a risk of explosion. The affected product was sold to salons and retailers across the U.S. Henkel learned of the issue through one customer complaint and two salon reports, with one instance of hand bruising reported.

Serious·FDA·Aug 11, 2026·Schwarzkopf Professional

Fresenius Kabi recalled one lot of Tyenne (tocilizumab-aazg) Injection 400 mg/20 mL vials after discovering the product contains glass particles. The affected lot was distributed nationwide to hospitals, clinics, and distributors.

Serious·FDA·Aug 10, 2026

Victory Medical Center Pharmacy identified elevated bacterial endotoxin levels in certain lots of its compounded glutathione 200 mg/mL multi-dose vials used for injection. Endotoxin contamination can cause serious reactions including fever, low blood pressure, severe headache, and in rare cases, anaphylactic shock or death. The pharmacy has received reports of adverse events from patients who received the product.

Serious·FDA·Aug 5, 2026·Victory Medical Center Pharmacy

Fresenius Kabi recalled one lot of Morphine Sulfate Injection 2 mg/1 mL prefilled syringes due to a labeling error. Packages labeled as morphine may actually contain Dilaudid (hydromorphone), a different and more potent opioid. Using the wrong medication could cause serious respiratory problems or death, especially in patients not used to opioids or those with lung disease.

Serious·FDA·Aug 4, 2026

BD is recalling specific lots of its Intraosseous Vascular Access System Needle Sets because some users have had difficulty removing the obturator (stylet) after needle placement. The affected needle sets were manufactured with out-of-tolerance dimensions and distributed between September 2024 and June 2026. If the obturator cannot be removed, clinicians may need to obtain alternative vascular access, potentially delaying urgent care.

Serious·FDA·Jul 30, 2026

Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.

Serious·FDA·Jul 29, 2026·Penumbra

Medline is recalling 370 medical procedure convenience kits across two product entries. The kits include pain management kits made by ICU Medical that contain bupivacaine hydrochloride in dextrose injection, which was recalled over quality issues that could make the drug less effective. No injuries have been reported, and the kits were distributed in Missouri, Colorado, and Illinois.

Serious·FDA·Jul 29, 20262 products

Boston Scientific identified that certain lots of the FARADRIVE Steerable Sheath (CLEAR) may have a hemostatic valve that can be damaged during device preparation if the dilator is not inserted correctly. Valve damage can allow air to enter, potentially causing an air embolism and patient harm.

Serious·FDA·Jul 29, 20264 products

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

Serious·FDA·Jul 29, 20263 products

Sunny Pharmtech is recalling three lots of Cyclophosphamide for Injection (1g and 2g vials) distributed between May 2024 and October 2024 because steel particles were found in the product. No injuries have been reported so far, but steel particles in an intravenous injection could cause serious complications including blood clots and infection.

Serious·FDA·Jul 24, 2026·Sunny Pharmtech

Baxter is recalling one lot of Cefazolin in Dextrose Injection (a frozen antibiotic infusion bag) because cardboard particles were found in the solution. The affected lot (LD175708, expiring February 14, 2027) was distributed between March and June 2025. No injuries have been reported so far.

Serious·FDA·Jul 24, 2026

American Regent identified glass and paraformaldehyde particles in one lot of Papaverine Hydrochloride Injection (Lot #25202), a prescription medication used to improve blood circulation and treat muscle spasms. The particles could cause local irritation, blood vessel blockage, and serious complications including stroke.

Serious·FDA·Jul 24, 2026

GE HealthCare identified that certain Optima XR200/220/240amx systems that underwent column replacement may not have had proper safety testing after assembly. If an internal cable fails, the safety mechanism could malfunction, allowing the X-ray arm to drop unexpectedly during patient exams.

Serious·FDA·Jul 22, 20263 products

ICU Medical is recalling two infusion pump products, the Plum Duo and Plum Solo Precision IV Pump, because in a specific scenario the pump may not count down the Volume to be Infused on its Delivery screen and could deliver up to twice the programmed volume at the set rate. The recall covers about 17,584 units distributed across the US and Canada, and no injuries have been reported.

Serious·FDA·Jul 22, 20262 products

Argon Medical Devices is recalling six procedure trays and kits, including the Transvenous Pacing Electrode Tray, One-Piece Introducer Tray, General Biopsy Tray, T-Lok Bone Marrow Tray, Arterial Line Kit, and Bone Marrow Tray. Some kits contain lidocaine ampules that are already subject to another recall, and the kits did not meet sterility release criteria. No injuries have been reported.

Serious·FDA·Jul 22, 2026·Argon Medical Devices6 products

Abiomed is recalling 13 Impella heart pump sets and introducer kits because the introducer sheath may leak from under the sheath cap and along the hub score lines. The problem affects 14Fr and 23Fr introducers, which come in every pump set, and users cannot see it visually. No injuries have been reported.

Serious·FDA·Jul 22, 202613 products

Abiomed's Impella Introducer Kit (Hemostatic Peel Away Introducer System) may have manufacturing defects that cause the 14Fr and 23Fr introducer sheaths to leak from multiple locations: the sidearm, under the sheath cap, and along hub seams. This affects 355 units distributed in Massachusetts.

Serious·FDA·Jul 22, 2026·Oscor3 products

Four lots of Unique Pharmaceutical Cetirizine Hydrochloride 5 mg tablets were found to be cross-contaminated with ranitidine. The contamination was discovered when pharmacy staff noticed red discoloration on some tablets. People with sensitivity to ranitidine could experience serious allergic reactions.

Serious·FDA·Jul 18, 2026

Trafa Pharmaceuticals Inc. is recalling its organic moringa leaf powder (15 kg bags, batch #TRF-2025050801, manufactured May 8, 2025) due to potential Salmonella contamination. The affected product was distributed in New York.

Serious·FDA·Jul 15, 2026

Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.

Serious·FDA·Jul 8, 2026·Medtronic Heart Valves Division

Windstone Medical's AMS Preop Kit-NS surgical convenience kits contain Webcol Large Alcohol Prep Pads that were recalled due to bacterial contamination (Paenibacillus phoenicis) discovered during sterilization testing. The contamination was identified by Cardinal Health, the pad manufacturer. About 200 kits with specific lot codes are affected.

Serious·FDA·Jul 8, 20264 products

Specific lots of Medline reprocessed St. Jude Medical Response diagnostic electrophysiology catheters may contain small particles of residual material on surfaces that contact patients. If these particles dislodge during use, they could potentially cause blood clots, inflammation, or infection.

Serious·FDA·Jul 8, 2026

Medline Convenience kits contain Swan-Ganz catheters with a defective connector (blue hub) that can leak, break, or damage the internal lumen. This defect may lead to medication loss, blood loss, or infection during medical use.

Serious·FDA·Jul 8, 20268 products