Amneal Recalls traMADol Tablets Due to Impurity Risk

This alert was compiled from official government recall data published by the FDA using automated analysis. All facts are sourced directly from official records. Last verified April 14, 2026.

Heads Up: Important Recall Alert for Tramadol Hydrochloride Tablets

If you or someone you know uses traMADol Hydrochloride Tablets, listen up. Amneal Pharmaceuticals LLC has issued a voluntary product recall in the United States for a specific lot of their 50 mg, 500-count bottles. This recall affects prescription-only traMADol Hydrochloride Tablets, USP, due to a failed impurity test. Specifically, the N-nitroso-desmethyl-tramadol impurity (NDSRI) was found to be out of specification during long-term stability testing.

Nobody wants to find out their medication is being recalled, but it's crucial to take swift action to protect your health. This announcement, dated April 8, 2026, comes directly from the U.S. Food and Drug Administration (FDA) and impacts medications that have been sold across the U.S.

What's the Problem? Understanding the Recall

The reason for this product recall in the United States is the detection of N-nitroso-desmethyl-tramadol impurity (NDSRI) exceeding acceptable limits during routine stability testing. According to the Amneal Pharmaceuticals LLC recall announcement, the affected traMADol Hydrochloride Tablets, USP, 50 mg were found to have this impurity at the 24-month stability interval during long-term stability testing (25°C/60%RH).

Here's what you need to know:

• This is a Class II recall, meaning that exposure to this product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• The affected tablets are packaged in 500-count bottles, Rx only.
• The impurity, N-nitroso-desmethyl-tramadol (NDSRI), is the key concern.

While adverse effects are considered medically reversible based on this Class II recall, it's essential to take this seriously and follow the recommended steps. It's better to be safe than sorry when it comes to your health.

Which traMADol Hydrochloride Tablets Are Affected? Check Your Bottle!

It's critical to check your medication to see if it's part of this recall. Here are the specific details you need to know:

• Product: traMADol Hydrochloride Tablets, USP, 50 mg
• Packaging: 500-count bottles, Rx only
• Manufacturer: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India
• Distributor: Amneal Pharmaceuticals LLC, Glasgow, KY 42141
• NDC: 60219-2348-5
• Lot Numbers and Expiration Dates:
  • Lot #: AM230987, Exp. Date 05/2026
  • Lot #: AR232387, Exp. Date 12/2026
• Units Affected: 29,542 bottles. That's a lot of potentially impacted medicine distributed nationwide.

Check the label on your bottle of traMADol Hydrochloride Tablets immediately. If you find the matching lot number and expiration date, follow the steps outlined below.

What You Should Do Right Now

If you are a U.S. consumer who has purchased a bottle of Amneal Pharmaceuticals traMADol Hydrochloride Tablets 50mg with the affected lot numbers, here's what you need to do immediately:

1. Stop using the product immediately and contact your healthcare provider to discuss alternative treatment options, as stopping medication suddenly can have unintended consequences.
2. Contact your pharmacy to inquire about returning the affected medication safely, following their specific guidelines for drug disposal.
3. Contact Amneal Pharmaceuticals LLC directly with any questions or concerns you may have regarding this product recall in the United States and to report any adverse reactions you may have experienced.
4. Inform your doctor that you have been taking medication subject to this product recall, providing them with the lot number and expiration date of the affected tablets.

Amneal Pharmaceuticals and Recalls: What You Need to Know

Amneal Pharmaceuticals LLC is a pharmaceutical company that manufactures and distributes a variety of medications across the United States. While recalls are not uncommon in the pharmaceutical industry, it’s important for American shoppers to stay informed. This particular recall highlights the importance of rigorous quality control and testing procedures within the manufacturing process. Based on the official recall notice, Amneal Pharmaceuticals is working to address this issue promptly.

It is important to recognize that the U.S. Food and Drug Administration (FDA) oversees a huge number of recalls each year. They rigorously monitor the safety and efficacy of drugs sold countrywide. This recall is just one of many that happen regularly and are carefully overseen by the FDA.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.

Frequently Asked Questions

Q: Why is my traMADol Hydrochloride Tablets being recalled?

The traMADol Hydrochloride Tablets, USP, 50 mg are being recalled due to the presence of an impurity, N-nitroso-desmethyl-tramadol (NDSRI), which was found to be above acceptable levels during stability testing.

Q: What is N-nitroso-desmethyl-tramadol (NDSRI)?

N-nitroso-desmethyl-tramadol (NDSRI) is an impurity that was detected during testing; the presence of NDSRI above specification resulted in the recall of the mentioned lot numbers.

Q: What should I tell my doctor?

Inform your doctor immediately that you have been taking traMADol Hydrochloride Tablets from the affected lot (AM230987 or AR232387) and discuss alternative treatment options.

Q: What if I experienced side effects from the recalled medication?

Contact your healthcare provider immediately if you've experienced any adverse effects, and report these to the FDA's MedWatch program.

Q: Where was this medication sold?

The affected traMADol Hydrochloride Tablets were distributed nationwide within the USA; they wouldn't have been available at retailers like Walmart, Target, Amazon, or Costco because they are prescription-only medications.