June 2025 Drug Safety Update: Recalls of Carvedilol, Zicam Nasal Swabs, Generic Bactrim; New Warnings for Depakote and Lamictal; GLP-1 meds and Eye Disease (wet AMD)
Drug Recall: Sulfamethoxazole and Trimethoprim (Bactrim generic)
Amneal announced a recall of Bactrim generic tablets due to potential microbial contamination. Amneal is recalling 100 and 500 count bottles of Sulfamethoxazole and Trimethoprim 400 mg/80 mg strength tablets. Black spots found on the surface of a tablet were identified as the fungus Aspergillus. The product was distributed between December 2024 and May 2025 and has an expiration date of June 2027. The label indicates it was manufactured by Amneal in Ahmedabad, India. This medication is often used to treat urinary tract infections and ear or other respiratory infections. Example product label is posted below.
FDA Consumer Recall Announcement
Read or add patient reviews of Sulfamethoxazole/Trimethoprim at Ask a Patient. Last year, sulfa drugs had safety-related label updates:
Recall: Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, Orajel Baby Teething Swabs
Church & Dwight announced a recall of its homeopathic Zicam Cold Remedy Nasal Swabs, Zicam AllClear Nasal Cleaning Swabs and Orajel baby teething swabs due to potential microbial contamination (fungal) in the cotton swab part of the products. To date, no serious adverse events associated with the affected products have been reported. Check press release for product codes. Church & Dwight is offering a refund for recalled products.
FDA Consumer Recall Announcement and Church & Dwight Recall and Refund Information
Drug Recall: Carvedilol tablets (Coreg generic)
More than 200,000 bottles of 100 and 500-count 3.125 mg strength carvedilol tablets made by Glenmark are under recall due to nitrosamine impurities above the acceptable limit. Carvedilol is a “beta blocker” type of blood pressure drug and is a generic for Coreg brand name. This recall is directed at pharmacies and suppliers, but consumers may check the FDA Enforcement Report for lot numbers and expiration dates of affected products. The product label indicates Glenmark’s Goa, India facility as the manufacturing location.
This is the second recall of carvedilol by Glenmark this year. In February, 6.25 mg and 12.5 mg strength tablets were also recalled. Nitrosamine impurities occur due to manufacturing process problems. Check the Enforcement report for a list of lot numbers and expiration dates for recalled carvedilol, including an update of the recalled products from February.
In December 2022, Glenmark received a warning letter from the FDA after an inspection of its Mumbai, India facility found many deficiencies and violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Read or add patient reviews for Coreg or Carvedilol at Ask a Patient.
New Warning: Depakote (dlproex sodium) delayed-release tablets
Bipolar, seizure, and migraine headache prevention drug Depakote has a new warning about the risk of facial swelling (angioedema) and a serious drug hypersensitivity reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Depakote was approved in 1983. Symptoms of DRESS include fever, rash, facial swelling, enlarged lymph nodes and kidney or liver injury.
Depakote FDA Safety label change
Read more about drug hypersensitivity syndrome at the American Academy of Allergy, Asthma, and Immunology:
https://www.aaaai.org/conditions-treatments/related-conditions/dress
Patient reviews of Depakote
New Warning: Lamictal (lamotrigine) tablets, oral suspension, orally disintegrating tablets and extended release tablets
Bipolar drug and seizure drug Lamictal products have new warnings of potential interactions estrogen-containing drugs including oral contraceptives and hormone replacement therapy (HRT). Estrogen may reduce the effectiveness of Lamictal. Patients should notify their doctor if they use or plan to use estrogen-containing medications while taking Lamictal.
Safety Label Change: Lamictal, Lamictal CD, Lamictal ODT Lamictal XR (extended release tablets)
In 2018, the FDA issued a drug safety communication for Lamictal about a serious immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), which causes an uncontrolled response by the immune system. Like DRESS (mentioned above as a risk for Depakote), HLH has symptoms of fever, rash, and internal organ involvement. Lamictal was approved in 1994.
Research: GLP-1 Drugs and Risk of Eye Disease
A University of Toronto study found that diabetes patients who use GLP-1 drugs were twice as likely to develop neovascular age-related macular degeneration (nAMD) than diabetes patients not taking GLP-1 drugs. The two-fold increase in nAMD was most evident in people using these drugs for the longest period of time. The population-based retrospective cohort study included 139,002 patients with an average age of 66, including 46,334 patients who were exposed to GLP-1 drugs and 92,668 matched patients who had not taken GLP-1 drugs. The study was published in JAMA Ophthalmology.
Fierce Pharma: Diabetes patients who use GLP-1s may have a higher risk of serious eye disease
Review of Optometry: Glp1-drugs-linked-to-small-but-worrying increase in wet AMD risk
AMD is a leading cause of vision loss in people 50 years or older. Neovascular AMD (also known as “wet” AMD) is less common and more serious than “dry” AMD. With wet AMD, abnormal blood vessels grow under the retina, which may leak blood, causing serious vision problems or blindness. Learn more about the two types of Age-related Macular Degeneration from the American Academy of Ophthalmology, including descriptions of treatments, helpful vitamins, and an “Amsler grid” you can use to monitor your vision:
https://www.aao.org/eye-health/diseases/amd-macular-degeneration
Another serious eye condition, non-arteritic anterior ischemic optic neuropathy (NAION) has been linked to semaglutide, the ingredient in GLP-1 drugs Ozempic and Wegovy.
FDA Rolls Out Artificial Intelligence Tool
Martin Makary, FDA Commissioner, announced that he had set an aggressive timeline to scale the use of AI agency-wide: by June 30, 2025. In fact, the new tool was rolled out early, on June 2. The roll-out may have been premature. FDA staff found that the AI tool provided summaries about drugs that were either completely or partially wrong. Originally called CDER-GPT for use within the FDA's Center for Drug Evaluation and Research, it is now rebranded for use organization-wide as “Elsa.”
ARS Technica: “FDA rushed out agency-wide AI tool—it’s not going well”
Generic Drugs Concerns: Live Webcast on June 25
Have you ever noticed something different about a new generic drug you were taking? Usually there is no way to know if drug quality is to blame for new side effects or to explain why the drug is not working. Learn more about generic drug safety and quality and what you can do about it at an educational webinar for consumers hosted by MedShadow Foundation. The expert panel includes investigative journalists, pharmaceutical researchers, and patient advocates.
Program: “Investigating Generic Drugs: How Poor Quality Generics Cause Harm”
Host: Suzanne Robotti, Founder and President, MedShadow Foundation
Panelists: Katherine Eban, Journalist and Author, Bottle of Lies; Joe Graedon, President, The People’s Pharmacy; David Light, Co-founder and President, Valisure
When: June 25 at 4 pm Eastern Standard Time (sign up to receive access to the recording even if you can’t attend live)
Sign Up: https://medshadow.org/webinar-how-poor-quality-generic-drugs-cause-harm/
Related Reading: Check out our explainer article on ingredients variations in generic drugs, along with a description of Valisure’s Drug Quality Testing Project for the U.S. Defense Department.
Generic Drugs: Ingredients and Quality Concerns
Supplement Tips
Creatine is naturally stored in the muscles; when taken as a supplement it can boost muscle mass and performance. In her Friday Q&A, Dr. Lucy McBride, writer of “Are you Okay?” answers a question from a patient about creatine supplements:
”Is creatine worth trying for menopausal women who lift weights?”
https://lucymcbride.substack.com/i/165209594/question-creatine-supplements-and-menopause
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