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Nearly 750K eye drops recalled over sterility concerns. See list

Nearly 750K eye drops recalled over sterility concerns. See list

The recall covers nine products, including some sold at Walgreens, and 747,844 units in total.

Over half a million eye drops recalled. See affected products

Over half a million eye drops recalled. See affected products

Nearly 750,000 eye drops were recalled, including some Walgreens-branded bottles. Here's a look at the affected products.

FDA Recalls Eye Drops from Nine Brands Due to Sterility Concerns

FDA Recalls Eye Drops from Nine Brands Due to Sterility Concerns

The U.S. Food and Drug Administration (FDA) has issued a recall for hundreds of thousands of eye drop bottles sold under nine different brand names, including Walgreens. The recall stems from concerns that these products may not be sterile. The affected eye drops, manufactured by Sterling Pharmaceutical Services in Dupo, Illinois, include lubricant eye drops, lubricating tears, an eye solution, and an ointment. The FDA has classified this as a Class II recall, indicating that while exposure to the product could lead to temporary or reversible adverse health consequences, the likelihood of serious adverse health consequences is remote. Consumers are advised to check the lot numbers and expiration dates of their eye drops against the FDA's recall list and to discontinue use of any affected products immediately. This recall follows other recent eye drop recalls, including nearly 12 million bottles of Rohto eye drops in August and approximately 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops, b...

Flowers Foods Recalls Nature's Own Hawaiian Bread Due to Undeclared Milk Allergen

Flowers Foods Recalls Nature's Own Hawaiian Bread Due to Undeclared Milk Allergen

Flowers Foods, Inc. has issued a recall for its Nature's Own Hawaiian Bread, in both 20 oz. and 40 oz. bags, due to the presence of undeclared milk. This recall affects products distributed to retail customers in Arkansas, Louisiana, New Mexico, Oklahoma, and Texas. The company initiated the recall after a review of production records revealed that milk, a common allergen, was not listed as an ingredient on certain packages. The affected products have specific UPC numbers and product codes, along with 'Best if used by' dates ranging from October 8, 2026, to October 18, 2026. Consumers with milk allergies or severe sensitivities are at risk of an allergic reaction if they consume these products. To date, no illnesses or incidents related to this recall have been reported. This action is being taken with the knowledge of the U.S. Food and Drug Administration (FDA).

Semaglutide (Ozempic/Wegovy) Cleared by FDA to Reduce Cardiovascular Risks in Adults with Heart Disease and Obesity/Overweight

Semaglutide (Ozempic/Wegovy) Cleared by FDA to Reduce Cardiovascular Risks in Adults with Heart Disease and Obesity/Overweight

The U.S. Food and Drug Administration (FDA) has cleared semaglutide, marketed as Ozempic and Wegovy, to reduce the risk of heart attack, stroke, and cardiovascular death in adults diagnosed with established heart disease who also have obesity (BMI 30+) or are overweight (BMI 27+). This clearance follows findings from the landmark SELECT trial, summarized by Yale Medicine, which highlighted the medication's efficacy in this patient population. Semaglutide is a GLP-1 medication, one of the most prescribed in its class, and works by mimicking a naturally occurring hormone involved in appetite, satiety, glucose regulation, and digestion. While Ozempic is primarily used for type 2 diabetes treatment, and Wegovy is specifically approved for weight management, both contain the same active ingredient, semaglutide, and now share this expanded indication for cardiovascular risk reduction.

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

FDA Launches Expedited IND Pilot Program and Updates Non-Animal Testing Regulations

The U.S. Food and Drug Administration (FDA) has initiated an Expedited Investigational New Drug (IND) Pilot program, now accepting applications. This program aims to accelerate the drug development process by pairing drug sponsors with Qualified Research Institutions (QRIs) to support IND application preparation. The pilot allows for a rolling review of individual IND components during the pre-IND phase, rather than requiring a complete package upfront, with the goal of reducing clinical holds and shortening the drug-to-first-dose timeline. Applications for this pilot are due by October 30, and the FDA anticipates selecting 8–10 sponsor–QRI pairs for the initial cohort. Concurrently, the FDA has issued a direct final rule replacing 'animal tests' with 'nonclinical tests' in its drug and biologics regulations, explicitly allowing non-animal methods like human cell cultures, organs-on-chips, and computer models for pre-human safety assessment. This change does not eliminate animal studies but clarifies that ...

Fenbendazole Not Approved for Human Cancer Treatment, Poses Risks

Fenbendazole Not Approved for Human Cancer Treatment, Poses Risks

Fenbendazole, an antiparasitic medicine used in veterinary medicine to treat certain worm infections in animals, is not approved for human use in the United States, particularly for cancer treatment. Despite online discussions and personal testimonials suggesting its efficacy against cancer, there is no reliable clinical evidence to support these claims. The drug works by interfering with microtubules in parasites, which are also present in cancer cells, leading to scientific interest. However, laboratory findings and animal studies do not translate directly to safe and effective human treatments. The U.S. Food and Drug Administration has not approved fenbendazole for any human use, and there is no established, clinically validated dosing regimen for human cancer. Individuals considering or currently using fenbendazole for cancer are strongly advised to consult their oncology team to discuss potential risks and available evidence-based treatments.

DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

DHHS Releases 2026 Unified Agenda, Proposing Five Clinical Research Rule Changes

The Department of Health and Human Services (DHHS) has released its 2026 Unified Agenda, outlining five proposed regulatory shifts in clinical research. These changes represent the most concentrated set of proposed modifications to clinical research rules in years. Among the key proposals, the Office for Human Research Protections (OHRP) is considering revisions to 45 CFR 46 (RIN 0937-AA16). These revisions aim to introduce exemptions for low-risk research, provide flexibility for de minimis protocol changes, and reduce the burden on learning health systems. The overarching goal is to concentrate oversight on higher-risk activities. Additionally, the Food and Drug Administration (FDA) is targeting July 2026 for an expedited Phase 1 IND reform (RIN 0910-AJ30), which could revise sponsor responsibilities, risk-based exemptions, and Institutional Review Board (IRB) requirements in early development, with the explicit goal of reducing disproportionate burden. The FDA also lists a single IRB rule for cooperativ...

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics' PearlMatrix Bone Graft Receives Medicare NTAP Status, Accelerating Lumbar Fusion Reimbursement

Cerapedics Inc., a musculoskeletal company, has announced that its PearlMatrix P-15 Peptide Enhanced Bone Graft has been granted New Technology Add-On Payment (NTAP) status by the Centers for Medicare & Medicaid Services (CMS). This designation, effective October 1, 2026, provides supplemental Medicare reimbursement to hospitals and healthcare facilities utilizing PearlMatrix for skeletally mature patients with degenerative disc disease in the lumbar spine. PearlMatrix is a Class III drug-device combination product that has received U.S. FDA Breakthrough Device designation. The NTAP status was granted under CMS' alternative pathway, recognizing the product's transformative nature and its potential to address a critical need for faster fusion products. PearlMatrix is the first and only bone growth accelerator proven to substantially increase lumbar fusion speed, demonstrating superior results in a pivotal premarket approval study, including for high-risk patients.

FDA Closes Cyclospora Outbreak Investigation, Identifies Parasite in Mexican Farm Wastewater

FDA Closes Cyclospora Outbreak Investigation, Identifies Parasite in Mexican Farm Wastewater

The Food and Drug Administration (FDA) has closed its investigation into the largest Cyclospora outbreak in U.S. history, which sickened nearly 13,000 people. The FDA announced that its inspectors found the Cyclospora parasite in a wastewater tank and a drainage ditch at a Mexican farm linked to the outbreak. This farm, a supplier to Taylor Farms de Mexico, was previously identified as the source of contaminated iceberg lettuce. Despite the discovery, the FDA stated it remains unclear how the parasite initially contaminated the lettuce. Taylor Farms, in a separate statement, indicated that the independent grower responsible for the contamination is no longer part of their supplier program and their facility in central Mexico remains closed as they implement enhanced safety protocols.

FDA Warns Against Compounded Tirzepatide Due to Safety Risks

FDA Warns Against Compounded Tirzepatide Due to Safety Risks

The U.S. Food and Drug Administration (FDA) has issued a warning regarding compounded versions of tirzepatide, a drug used for weight loss. The FDA states that compounded tirzepatide poses higher safety risks compared to its FDA-approved counterparts. This is primarily because compounded versions bypass the rigorous federal testing processes that FDA-approved drugs must undergo. The agency emphasizes that these compounded drugs do not meet the same stringent standards for safety, quality, and effectiveness. The warning comes amidst growing interest in weight loss injections, prompting the FDA to highlight the potential dangers associated with unapproved formulations. The FDA's stance is that only FDA-approved drugs have been thoroughly evaluated for their intended use and have demonstrated a favorable risk-benefit profile.

Here's why experts say now is an ideal time to protect yourself from flu

Here's why experts say now is an ideal time to protect yourself from flu

Experts say now is an ideal time to get a flu shot, before influenza starts spreading widely