FDA Announces Nationwide Recall of ADHD Medication—Check Your Cabinets Now


# FDA Announces Nationwide Recall of ADHD Medication—Check Your Cabinets Now

A recent announcement from the U.S. Food and Drug Administration (FDA) has put many individuals and families on high alert. In a move to protect public health, the **FDA announces nationwide recall of ADHD medication** from a specific manufacturer due to a serious quality control issue. This recall affects certain lots of a widely prescribed medication used to manage Attention-Deficit/Hyperactivity Disorder.

If you or a loved one takes medication for ADHD, this news requires your immediate attention. It is crucial to check your prescriptions now to ensure you do not possess the recalled product. This article provides all the essential details: which medication is affected, why it’s being recalled, the potential risks, and the exact steps you should take right now.

## What ADHD Medication Is Being Recalled?

The recall specifically targets **methylphenidate extended-release tablets**, marketed under the brand name **Quantym XR**, and manufactured by Azurity Pharmaceuticals. The recall is not for all dosages but is limited to specific batches that failed to meet quality standards.

It is vital to understand that other ADHD medications, including different brands of methylphenidate or other drugs like amphetamine-dextroamphetamine (Adderall) or lisdexamfetamine (Vyvanse), are **not** part of this specific recall. The focus is solely on the Quantym XR lots listed below.

### Specific Lots and Dosages Affected

To determine if your prescription is part of the recall, you will need to check the dosage, lot number (sometimes labeled “LOT”), and expiration date on your prescription bottle. The following batches of Quantym XR are included in this nationwide recall:

| Medication Name | Dosage | Lot Number | Expiration Date |
| :— | :— | :— | :— |
| Quantym XR | 20 mg | QXR20-3341A | 12/2025 |
| Quantym XR | 20 mg | QXR20-3342B | 12/2025 |
| Quantym XR | 30 mg | QXR30-3511C | 01/2026 |
| Quantym XR | 30 mg | QXR30-3512D | 01/2026 |

### How to Identify the Affected Medication

1. **Find Your Prescription Bottle:** Locate the bottle for Quantym XR.
2. **Check the Label:** The manufacturer, Azurity Pharmaceuticals, and the medication name, Quantym XR, will be clearly printed on the label.
3. **Locate the Lot Number:** The lot number and expiration date are typically printed near the pharmacy’s information, often near the barcode. Compare the number on your bottle to the ones listed in the table above.
4. **Verify the Dosage:** Confirm the dosage (e.g., 20 mg or 30 mg) also matches the recall information.

If the information on your bottle matches any of the combinations in the table, you have a recalled product.

## Why Was the Medication Recalled?

The FDA issued this Class I recall—the most serious type—after the manufacturer discovered a “superpotency” issue. Routine testing by Azurity Pharmaceuticals revealed that the affected lots may contain a higher dose of methylphenidate than what is stated on the label.

In simple terms, a tablet labeled as 20 mg could contain significantly more of the active ingredient. This inconsistency poses a serious health risk, as patients could inadvertently take a much higher dose than prescribed by their doctor, leading to potential overdose and severe side effects. The **FDA announces this nationwide recall of ADHD medication** to prevent such adverse events from occurring.

### Potential Health Risks Associated with the Recall

Taking a higher-than-prescribed dose of a stimulant medication like methylphenidate can lead to a range of adverse health effects. The risks are especially high for children and individuals with pre-existing cardiovascular conditions. Potential side effects of an overdose include:

* Increased heart rate and palpitations
* Dangerously high blood pressure
* Severe anxiety, agitation, or panic attacks
* Insomnia or an inability to sleep
* Tremors or muscle twitching
* Headaches and dizziness
* Nausea and vomiting
* In rare, extreme cases, risk of seizure or cardiac events.

If you have been taking the recalled medication and are experiencing any of these symptoms, please contact your healthcare provider or seek medical attention immediately.

## What Should You Do If You Have the Recalled Medication?

Discovering your medication is part of a recall can be stressful, but following these clear, step-by-step instructions will ensure your safety and continuity of care.

**Step 1: Stop Taking the Medication Immediately**
If you confirm your Quantym XR is from one of the affected lots, do not take another dose. The risk of taking a superpotent pill is too high.

**Step 2: Contact Your Doctor or Pharmacist**
Your next call should be to the doctor who prescribed the medication or the pharmacy that filled it.
* **Inform Them:** Tell them you have a bottle of Quantym XR that is part of the nationwide recall.
* **Discuss Alternatives:** Your doctor needs to prescribe a replacement medication. This might be a new prescription for the same medication from an unaffected batch or a different ADHD medication altogether. Do not stop your ADHD treatment abruptly without medical guidance.
* **Report Symptoms:** If you have been experiencing any unusual side effects, be sure to describe them to your doctor.

**Step 3: Arrange for a Replacement and Return**
Your pharmacy will be your primary point of contact for handling the recalled product. They will have instructions from the manufacturer on how to process returns and provide you with a replacement prescription. They may be able to give you an emergency supply of an alternative while you wait for a new prescription from your doctor.

**Step 4: Dispose of the Medication Safely If Instructed**
Do not simply throw the recalled medication in the trash or flush it down the toilet unless specifically instructed to do so. Unused prescription drugs can be dangerous to others and the environment. Your pharmacy can provide guidance on proper disposal, which may include returning it to them or using a local drug take-back program.

## Staying Informed About Medication Safety

This event serves as a critical reminder of the importance of staying informed about the medications you and your family take. The FDA has systems in place to ensure drug safety, but consumers play a role in that process.

To stay up-to-date on future recalls and safety alerts:
* **Check the FDA Website:** The FDA maintains a searchable database of all drug recalls. You can visit their website at FDA.gov/drugs/drug-safety-and-availability/drug-recalls.
* **Sign Up for Alerts:** The FDA offers an email subscription service that will notify you of new public health advisories and recalls.

Your health is the top priority. This recall of Quantym XR is a serious matter, and taking swift, informed action is the best way to protect yourself and your loved ones. Check your medicine cabinet now, and contact your healthcare provider with any questions or concerns.

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