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Apotex Corp. is recalling one lot of Paxil CR (paroxetine) 37.5mg extended-release tablets because the medication failed to meet dissolution specifications during 24-month stability testing. This means the tablets may not release the drug into the body as intended. The affected lot (TY9494, expiration 05/31/2027) was distributed nationwide.

Moderate·FDA·Sep 2, 2026

Mallinckrodt has recalled specific lots of Acthar Gel (repository corticotropin injection) due to the presence of glass and stopper pieces in the vials. This contamination could pose a risk if the affected medication is used. The recall affects 12,367 vials with lot numbers 1564-107 and 1564-107H, both expiring January 31, 2027.

Moderate·FDA·Sep 2, 2026·Mallinckrodt

FDA inspection found that Zicam Cold Remedy Medicated Nasal Swabs failed microbiological testing, meaning they may contain harmful microbes. The affected products were manufactured under conditions that did not meet federal safety standards. Specific lot numbers with expiration dates through August 2028 are involved.

Moderate·FDA·Sep 2, 2026·Arm & Hammer

Lupin Pharmaceuticals is recalling specific lots of Clobetasol Propionate Cream USP 0.05% because the active ingredient is not uniformly distributed throughout the product. This means some parts of the cream may contain too much or too little medication, which could affect how well it works.

Moderate·FDA·Sep 2, 2026

Accord Healthcare is recalling specific lots of levothyroxine sodium tablets (25 mcg) because they contain less active ingredient than labeled. Patients taking these tablets may not receive the full dose needed to manage their thyroid condition. The affected lots were distributed nationwide.

Moderate·FDA·Sep 2, 2026·Accord Healthcare12 products

American Contract Systems is recalling 2 lines of medical procedure kits and trays, 4,949 kits in total, distributed in Minnesota, Missouri, and Iowa. The recall follows Medicom's recall of specific lots of Ritmed Neurological Sponges, which may have unexpectedly variable endotoxin levels. No injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

restor3d Inc. is recalling specific lots of the Veritas Standard Glenoid Baseplate used in reverse shoulder replacement surgery. A manufacturing error created incorrectly machined screw holes that may prevent peripheral screws from engaging properly during surgery. The defect affects only the standard baseplate; patient-specific baseplates are not affected.

Moderate·FDA·Aug 26, 2026

ConvaTec's Esteem Body Soft Convex Urostomy Pouches may leak from the cap during normal use. This affects multiple model numbers distributed nationwide across the U.S. No injuries have been reported to date.

Moderate·FDA·Aug 26, 2026·ConvaTec

Medtronic is recalling three MiniMed insulin pump models (640G, 670G, and 780G) that were loaned out and may have been cleaned with products that are incompatible with the pump. This could damage the case or keypad, let moisture in, and cause the pump to deliver too much or too little insulin. No injuries have been reported. The recall covers 280 affected pumps and was distributed in several European countries.

Moderate·FDA·Aug 26, 20263 products

A software defect in Beckman Coulter's DxC 500 AU Clinical Analyzer (software version 1.5 or lower) can silently overwrite customized test calculation rules when a new Parameter Package is imported. This may cause the analyzer to generate incorrect patient test results without alerting the operator to the problem. The issue only occurs when updating an existing system; newly installed systems are not affected.

Moderate·FDA·Aug 26, 2026

Paragon 28 is recalling two custom-made navicular cage foot implants because their oxygen level is above the allowed limit. Elevated oxygen may reduce the metal's ductility, meaning it may be less able to bend before breaking. The devices were distributed across the US, and no injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

The Blanketrol II Model 222S thermal regulating system may experience overheating of its 115V CPU board, which can cause the device to shut down unexpectedly. This affects 182 units distributed worldwide. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Gentherm Medical

Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen test kits may incorrectly report positive syphilis results as negative. This could allow infected patients to go undiagnosed. The affected lot codes are L2KSY2/10489085 and L2KSY6/10488319.

Moderate·FDA·Aug 26, 20262 products

Halyard LAVH PACK surgical kits (Model USAR053-11) containing Clearify Visualization System components were sterilized using ethylene oxide (EO) in a way that did not follow manufacturer instructions. This improper sterilization may have caused a kit component to leak.

Moderate·FDA·Aug 26, 2026

Boston Scientific is recalling two Suture Cinch endoscopic tissue approximation devices, the OverStitch Suture Cinch and the Suture Cinch Long. The devices may fail to deploy the cinch implant or fail to cut the suture as intended. The recall covers 60,654 units of each product, distributed in the US and many other countries. No injuries have been reported.

Moderate·FDA·Aug 26, 20262 products

The battery mounting tabs in some TD Navio Midi speech-generating devices may become damaged, allowing the battery to shift inside the device. This can cause an internal short circuit, leading to localized heating and gas venting inside the device enclosure.

Moderate·FDA·Aug 26, 2026

The ARVIS Surgical Navigation System Gen 2, a computer-controlled device used by surgeons to help position orthopedic implants during knee, hip, and shoulder surgery, has a sensor issue that can cause the image displayed through the eyepiece to appear tilted. This misalignment could affect the accuracy of surgical guidance if the surgeon relies solely on the displayed image without cross-checking with other alignment methods.

Moderate·FDA·Aug 26, 2026·Kico

The Philips Cardiac Workstation 5000 (Product Number 860439) can intermittently display inaccurate native heart rate data. This may affect the reliability of heart rate measurements used in clinical decision-making. The issue has been identified in approximately 796 units distributed worldwide.

Moderate·FDA·Aug 26, 20262 products

Intersurgical is recalling two sizes of its One-Piece Guedel Airway, a device used to keep a patient's airway open. The devices could be blocked or partly blocked, and about 22,844 units are affected. They were distributed nationwide, with US distribution in CT, FL, IN, MI, OH, and VA, and no injuries have been reported.

Moderate·FDA·Aug 26, 2026·Intersurgical2 products

Foundation Medicine's Protocol Configuration Tool (PCT) v2.0.0, used with Hamilton Microlab STAR liquid handlers to conduct F1CDx and F1LCDx tests, has a software issue that can cause the application to close unexpectedly. This affects 32 units distributed in Massachusetts and North Carolina.

Moderate·FDA·Aug 26, 2026

The EndoFLIP endoscopic measuring system has a 24-hour usage limit that causes catheters to be incorrectly marked as expired. This prevents catheters from being used in clinical procedures even though they may still be suitable for use.

Moderate·FDA·Aug 26, 2026

Spectral Instruments is recalling 75 units across two products: 40 Lago X and 35 Ami HTX. The on-screen "X-Ray On" banner can briefly be absent during the run readiness check. No injuries have been reported.

Moderate·FDA·Aug 26, 2026·Spectral Instruments2 products

American Regent is recalling 12 injectable and oral solution products, including nitroglycerin, cyanocobalamin (vitamin B12), aminocaproic acid, atropine, acetylcysteine, selenious acid, papaverine, niCARdipine, and the trace element products Multrys and Tralement. Some vials may contain particulate matter identified as hair, glass, and/or paraformaldehyde. No injuries have been reported.

Moderate·FDA·Aug 26, 202612 products

Mylan Pharmaceuticals is recalling one lot of Acamprosate Calcium 333 mg delayed-release tablets because they failed to meet dissolution specifications—meaning the tablets may not break down and release the medication as intended in the body. This could result in ineffective treatment. No injuries have been reported.

Moderate·FDA·Aug 26, 2026

Golden State Medical Supply is recalling Carbamazepine Tablets, USP 200mg due to black specks found in some tablets. This is a manufacturing quality issue. The affected lots were distributed nationwide.

Moderate·FDA·Aug 26, 2026

Sun Pharmaceutical's Carbamazepine 200mg tablets (Lot #AD94033, expiring 5/31/2028) contain black spots caused by burnt ingredients during manufacturing. The tablets do not meet quality standards, though no injuries have been reported.

Moderate·FDA·Aug 26, 2026

Regeneron is recalling one lot of Libtayo (cemiplimab-rwlc), an intravenous cancer treatment, because the manufacturer cannot guarantee the vials are sterile. This affects lot 8494000002, which expires July 31, 2028. About 21,353 vials are involved in the recall nationwide.

Moderate·FDA·Aug 26, 2026·Regeneron

Certain vials of PEMRYDI RTU (pemetrexed injection) have developed green to dark green discoloration. The affected lots are P400172 and PA00050A, expiring 09/30/2027. Discoloration may indicate a quality issue with the medication.

Moderate·FDA·Aug 26, 2026·Shilpa Medicare2 products

Vitruvias Therapeutics is recalling one lot (504950) of Thyroid Tablets, USP 30 mg because testing found the tablets may contain higher-than-intended amounts of thyroid hormone. Taking overly potent thyroid medication can cause an overactive thyroid, leading to weight loss, rapid heartbeat, chest pain, and other serious symptoms, especially in elderly people, pregnant women, and infants.

Moderate·FDA·Aug 21, 2026·Vitruvias Therapeutics

Heritage Pharmaceuticals' clindamycin palmitate hydrochloride oral solution (75 mg/5 mL) has been recalled due to the presence of particles and white flakes found in reconstituted bottles. The affected lot is 2411550, which expires November 2026. This product was distributed nationwide.

Moderate·FDA·Aug 19, 2026·Heritage Pharmaceuticals