Patient Safety and Pharmacology: What Drugs Have Been Recalled Recently?

October 12, 2025 •

3 min read

Each year, the U.S. Food and Drug Administration (FDA) oversees the removal of numerous drug products from the market to protect public health. Understanding what drugs have been recalled recently is a critical component of patient safety and awareness.

Quick Summary

An overview of recent 2025 drug recalls, detailing specific medications, the reasons for their removal, and the potential risks involved. This summary explains FDA recall classifications and patient actions.

Key Points

Three Classes: The FDA uses three recall classifications: Class I (most serious), Class II, and Class III (least serious).
Recent 2025 Recalls: Notable recent recalls include Cyclobenzaprine for mislabeling and various IV fluids for particulate matter.
Patient Action: If your medication is recalled, do not stop taking it; contact your doctor and pharmacist first for guidance.
Check Lot Numbers: Recalls often pertain to specific manufacturing lots, so check your prescription bottle for this information.
Stay Informed: The FDA's official website is the most reliable source for up-to-date information on drug recalls and safety alerts.
OTC Recalls: Both prescription and over-the-counter (OTC) drugs, like certain Zicam and Orajel products, are subject to recalls.
Reporting Problems: Patients and healthcare providers can report adverse events with medications to the FDA's MedWatch program.

The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs, and a key part of this role involves overseeing drug recalls. A recall is an action taken by a company to remove a product from the market, which can be done on the firm's own initiative, at the FDA's request, or by FDA order. These actions are a crucial mechanism for protecting the public from defective or potentially harmful medications. Reasons for recalls vary widely and can include contamination, incorrect labeling, improper dosage, or manufacturing defects.

Understanding Drug Recall Classifications

The FDA categorizes recalls into three classes based on the level of potential health hazard.

Class I Recall

This is the most serious type of recall, where there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Class II Recall

This class is for products that may cause temporary or reversible adverse health consequences, or where the likelihood of serious effects is low.

Class III Recall

This is the least severe classification for products unlikely to cause adverse health reactions but still violate FDA regulations.

Notable Drug Recalls of 2024-2025

Staying informed about recent recalls is essential. Notable recalls from late 2024 and 2025 include Bupropion Hydrochloride Extended-Release Tablets, Lorazepam Injection, Cyclobenzaprine Hydrochloride Tablets due to mislabeling, Lactated Ringer's and Sodium Chloride Injection for particulate matter, DermaRite OTC products for potential contamination, Zicam® and Orajel™ swabs due to microbial contamination, Fentanyl Transdermal System, and Levothyroxine Sodium Tablets.

Comparison of Recent Recalls


Drug Name	Manufacturer	Reason for Recall	Date of Recall Notice
Cyclobenzaprine HCl Tablets	Unichem Pharmaceuticals	Mislabeling	August 27, 2025
Lactated Ringer's Injection	B. Braun Medical, Inc.	Presence of particulate matter	August 19, 2025
Zicam® Cold Remedy Swabs	Church & Dwight Co., Inc.	Microbial contamination	June 6, 2025
Fentanyl Transdermal Patch	Alvogen, Inc.	Potential for overdose causing respiratory depression	February 3, 2025
Metoclopramide Tablets	Teva Pharmaceuticals	A different drug (Torsemide) was found in bottles	May 28, 2025

What to Do If Your Medication Is Recalled

If you learn that a medication you are taking has been recalled, it is important to act carefully.

Do Not Stop Taking the Medication: Do not abruptly stop taking a prescribed medication. Consult your doctor first.
Check the Lot Number: Verify if your medication's lot number matches the recalled lots. Your pharmacy can assist if needed.
Contact Your Doctor and Pharmacist: Seek guidance from your healthcare provider and pharmacist regarding instructions and alternatives.
Follow Disposal Instructions: If advised to stop, dispose of the medication properly, often through pharmacy take-back programs.

How to Stay Informed

The most reliable source for information is the FDA. You can visit the FDA's drug recall website, sign up for email alerts, or follow the FDA's social media channels for updates. The FDA MedWatch program is another vital resource for reporting adverse events and staying informed about safety issues.

For the most current information, you can visit the FDA's Drug Recalls page.

Conclusion

Drug recalls are an essential safety measure in the pharmaceutical landscape. While they can be concerning, they demonstrate that monitoring systems are in place to protect patients. By understanding recall classifications, staying informed about recent events, and knowing what steps to take, consumers can play an active role in their own health and safety. Always consult with healthcare professionals before making any changes to your medication regimen..

Frequently Asked Questions

A drug recall involves removing a product that violates FDA law, posing a potential health risk. A market withdrawal is typically initiated by a company for a minor issue that does not violate regulations, such as for stock rotation or correcting a minor product defect.

Drug recalls usually specify the lot or batch numbers affected. You can find this number on your prescription bottle or packaging. Your pharmacist can also verify if your specific medication is part of the recall.

No, you should not stop taking a prescription medication without first consulting your doctor or pharmacist. The risk of stopping the medication may be greater than the risk associated with the recall.

The FDA oversees the recall process. While most recalls are voluntary by the manufacturer, the FDA can request or mandate a recall. The agency classifies the recall's severity and ensures the company's strategy is adequate to protect public health.

Yes, over-the-counter medications are also monitored by the FDA and can be recalled for the same reasons as prescription drugs, such as contamination, incorrect labeling, or manufacturing defects.

You can report adverse events directly to the FDA through its MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online, by mail, or by fax.

For over-the-counter medications, you can often return the product to the place of purchase for a refund. For prescription drugs, you should consult with your pharmacist, who can advise on replacement medication or potential reimbursement.