In 2025, the pharmaceutical industry has witnessed a series of significant drug recalls, underscoring the ongoing challenges in ensuring medication safety and quality. These recalls have spanned various therapeutic areas, from potent opioids to common over-the-counter acne treatments, highlighting the importance of stringent manufacturing practices and regulatory oversight.

Fentanyl Patch Recall Due to Packaging Defect

In January, Alvogen, Inc. issued a voluntary nationwide recall of one lot (108319) of its Fentanyl Transdermal System 25 mcg/h patches. The recall was prompted by a packaging defect that caused multiple patches to adhere together within a single pouch. This defect posed a significant risk of accidental overdose, potentially leading to serious or fatal respiratory depression, especially in first-time users, children, and the elderly. The affected lot, with an expiration date of April 2027, was distributed nationwide at both pharmacy and patient levels. Alvogen reported one serious adverse event associated with this issue and coordinated with the Food and Drug Administration (FDA) to facilitate the recall process ^1,2.

ICU Medical’s Potassium Chloride Injection Mislabeling

In February, ICU Medical, Inc. issued a nationwide recall of one lot each of Potassium Chloride Injection 20 mEq and 10 mEq due to mislabeling. Bags labeled as 10 mEq contained 20 mEq, posing a risk of overdose. An overdose of potassium chloride can lead to severe hyperkalemia, causing neuromuscular dysfunction, cardiac dysrhythmias, or even death from cardiac arrest. No adverse events were reported at the time of the recall ^3,4.

Benzene Contamination in Acne Treatments

Earlier this year, concerns arose over benzene contamination in several acne treatment products containing benzoyl peroxide. Valisure, an independent laboratory, detected elevated levels of benzene, a known carcinogen, in certain products. Subsequent FDA testing confirmed these findings, announced in an alert in March 2025, leading to voluntary recalls of specific lots of products from brands such as La Roche-Posay, Proactiv, Walgreens, SLMD, and Zapzyt containing this drug. The FDA emphasized that while the risk of cancer from these products is low, the recalls were precautionary measures to ensure consumer safety. Retailers were instructed to remove the affected products from shelves, and consumers were advised to discontinue use and dispose of any expired products ^5,6.

Glenmark Pharmaceuticals’ Generic Drug Recall

In March, the FDA announced a nationwide recall of 30+ generic medications manufactured by Glenmark Pharmaceuticals at their facility in Madhya Pradesh, India. Initiated on March 13 and classified as a Class II recall on April 8, these drugs were found to deviate from current good manufacturing practices. Affected medications include treatments for high cholesterol, atrial fibrillation, seizures, high blood pressure, and seasonal allergies, among others. The recalled products were distributed across the U.S., primarily through pharmacies, with some over-the-counter products like acetaminophen and cetirizine hydrochloride sold via Amazon and Walmart, although no specific health injuries were reported ^7,8.

Dr. Reddy’s Levetiracetam Injection Mislabeling

In March, Dr. Reddy’s Laboratories Ltd. recalled one lot of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL, due to mislabeling. The infusion bag was incorrectly labeled as containing 500 mg/100 mL, while it actually contained 1,000 mg/100 mL. This discrepancy could lead to patients receiving double the intended dose, potentially resulting in serious side effects such as hypersensitivity reactions, liver injury, hematological toxicity, and respiratory depression. No adverse events were reported at the time of the recall ^9,10.

These drug recalls in early 2025 underscore the importance of robust quality control measures, vigilant regulatory oversight, and consumer awareness in the pharmaceutical landscape. As the year progresses, continued diligence from manufacturers, regulators, and consumers alike will be essential in maintaining medication safety and efficacy.

References

1. Fentanyl Transdermal System 25 patches recalled nationwide. https://www.houstonchronicle.com/news/houston-texas/trending/article/fentanyl-patches-recall-20150986.php.

2. Investigations, O. of I. and. Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective (2025).

3. ICU Medical recalls certain lots of potassium chloride injection bags due to mislabeling | AHA News. https://www.aha.org/news/headline/2025-02-19-icu-medical-recalls-certain-lots-potassium-chloride-injection-bags-due-mislabeling.

4. Investigations, O. of I. and. ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride (2025).

5. Stangland, S. 7 acne treatments recalled for elevated levels of benzene. (2025). https://publications.aap.org/aapnews/news/31630/7-acne-treatments-recalled-for-elevated-levels-of

6. Drugs.com. Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination. FDA (2025). https://www.drugs.com/fda/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-14736.html

7. Glenmark, Biocon units recall products in US: USFDA – The Economic Times. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-biocon-units-recall-products-in-us-usfda/articleshow/120129463.cms?from=mdr.

8. Landwehr, J. Nationwide Recall Hits Dozens of Common Generic Drugs—What You Need to Know. Health https://www.health.com/fda-glenmark-recall-generic-drugs-11716765.

9. ET Online. Dr. Reddy’s recalls mislabelled Levetiracetam injection in the US; patients likely to experience ‘adverse’ events. The Economic Times (2025). https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-recalls-mislabelled-levetiracetam-injection-in-the-us-patients-likely-to-experience-adverse-events/articleshow/118979704.cms

10. FDA. Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-nationwide-recall-levetiracetam-075-sodium-chloride-injection-1000-mg100-ml-us-due (2025).