August 2025 Drug Safety: Huge Recall of Glaucoma Eye Drops; Duloxetine and Other Generic Recalls; HRT Comments; Opioid and Kratom 7-OH Warnings
Drug Recall: Duloxetine Tablets
Breckenridge is recalling more than 12,000 30-count bottles of duloxetine delayed release, 40mg tablets due to the presence of nitrosamine impurities above FDA recommended limit. Nitrosamine impurities can increase risk of cancer. The drug is manufactured by Towa Pharmaceuticals in Barcelona, Spain.
Duloxetine is generic for the antidepressant Cymbalta. The FDA classified the recall as class II on July 30, 2025. Breckenridge issued a larger recall, for over 343,000 bottles, for other lots and strengths of this drug April 2025. Check the enforcement report for specific lot numbers and expiration dates. This recall is at the retail level but consumers may wish check product names, lot numbers, and expiration dates here:
Recall Announcement
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Drug Recall: Lisdexamfetamine Capsules
Sun Pharmaceuticals is recalling 5,488 bottles of 100-count lisdexamfetamine dimesylate 60 mg capsules due to “failed dissolution specifications,” or problems with long-term stability of the drug. The capsules are manufactured in New Brunswick, NJ by OHM Labs for distribution by Sun Pharma. The recalled units were sent to 17 distributors who may have further distributed the product nationwide.
Lisdexamfetamine is a stimulant and also sold as an ADHD treatment under the brand names Vyvanse and Elvanse. The recall was initiated on June 16 and classified as a Class II recall on July 11, 2025. Lisdexamfetamine comes in strengths ranging from 10 mg to 60 mg.
Recall Announcement (enforcement report) for lot numbers and expiration dates
Read or add patient reviews for Vyvanse.
Drug Recall: Timolol Maleate Ophthalmic Eye Drops by FDC Ltd. and Apotex
FDC Limited is recalling 154,176 5 ml bottles and more than 60,428 10 ml bottles of .5% timolol maleate Ophthalmic eye drops made by FDC Limited in Aurangabad, Maharashtra, India due to a detective cap and container. The spike of the cap may be lodged in the nozzle of the product bottle. This medication is used to treat glaucoma and is distributed by Rising Sun Pharmaceuticals. The recalls were initiated in April and June 2025 and classified as a class II recall in July.
Recall Announcement for the 154K recall
Recall Announcement for the 60K recall
Read or add reviews for Timolol Maleate.
Another glaucoma treatment is being recalled by Apotex. More than 6,000 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL are under recall due to lack of sterility. The drops were manufactured by: Apotex Inc., Toronto, Ontario, Canada. Classified as Class II recall on June 25, 2025.
Recall Announcement for Apotex
More Generics Recalls
Additional recalls are underway for the generic medications omeprazole, budesonide, rizatriptan, clomipramine hydrochloride, and cinacalcet. Also, find out the details about recent recalls for sucralfate, levothyroxine, and gabapentin.
Menopause Hormone Therapy: Boxed Warnings May Be Removed from Some Labels
On July 17, the FDA hosted a panel of medical experts to discuss menopause hormone replacement therapy (HRT), focusing on balancing its benefits with potential health risks. Many experts argued that vaginal-only estrogen products are much safer than oral pills and shouldn’t carry the same strict “boxed” warning currently required for all estrogen therapies. They urged the FDA to remove the boxed warning for low-dose vaginal estrogen, noting it deters women from using treatments that could help with symptoms like vaginal dryness, hot flashes, and bone health.
The current boxed warnings were added after the 2002 Women’s Health Initiative (WHI) long-term study found that estrogen and progesterone therapies taken after menopause had significant health risks for cancer, heart disease, and stroke. Experts remain divided on whether the warnings should remain for other forms of HRT, such as oral or systemic (like gels or patches) options.
The FDA is seeking public comments about this topic. Comments must be submitted at regulations.gov by 11:59 p.m. ET on September 24, 2025 under docket number FDA-2025-N-2589.
Urology Times: “Experts Urge FDA to Remove Black Box Warning on Low Dose Vaginal Estrogen”
Not everyone thinks the warnings should be removed. For another perspective, read this editorial by Georgetown University’s Adriane Fugh-Berman, MD and Barbara Mintzes, Ph.D.:
American Family Physician: “Menopausal Hormone Therapy: Limited Benefits, Significant Harms”
Pain Treatments: Prescription Opioid Label Changes
FDA is giving opioid pain medicine makers just 30 days to update prescribing information with risk information about the dangers of long-term use and additional warnings and information about dosage, addiction, digestive issues, interactions with gabapentin, and more.
FDA Press Release: “FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks”
Kratom Products Under Scrutiny
The FDA sent warning letters to seven kratom vendors accused of illegally marketing kratom-derived “7-OH” dietary supplements. It has also launched a public awareness campaign about the dangers of these products. Kratom is a plant native to Southeast Asia and has been used for years in teas and as a dietary supplement for its anxiety-relieving properties. But in concentrated amounts, such are found in “herbal” drinks such as “Feel Free” sold in gas stations, the 7-OH substance, derived from the plant, can be highly addictive.
The FDA says it is specifically targeting 7-OH, a concentrated byproduct of the kratom plant and that it is not focused on natural kratom leaf products. It warns that 7-OH can have addictive qualities similar to opioids and serves no medical use.
The FDA is also calling on the DEA to classify 7-OH as a Federal Schedule 1 drug, which makes it illegal and places it in the same category as heroin. Those opposed to the illegal designation say that while regulation is needed, making it a Schedule 1 drug is an over-reaction. They say recent actions are influenced politically by a new group called the Global Kratom Coalition (GKC).
The Holistic Alternative Recovery Trust, an advocate for plant-based compounds to address opioid addiction, says that the FDA’s recommendation disregards how 7-OH is used in the real world.
Pain News Network: “FDA Warns About Kratom Extracts”
People’s Pharmacy: “What is Kratom and why does the DEA want to Ban it?”
FDA Press Release: “FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers”
More from FDA: FDA Resources on 7-OH with links to the letter sent to doctors warning about the emerging health dangers, Q&A for consumers, scientific data about 7-OH and more.
Note: you should have received two newsletters today: this edition for drug safety updates and another with highlights of new drug approvals and other treatments news.
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