Cipla Cinacalcet Tablets Recalled: Cancer 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 May 1, 2026.

Did you know that hundreds of drug recalls happen in the United States every year? It's a constant effort to keep medications safe for everyone. Now, here's a recall that U.S. consumers need to know about: a specific batch of Cinacalcet Hydrochloride Tablets is being pulled from shelves.

Cipla USA Recalls Cinacalcet Tablets

Cipla USA, Inc. has initiated a voluntary product recall in the United States for its Cinacalcet Hydrochloride Tablets, 30 mg. The problem? The tablets have been found to contain an impurity, N-Nitroso Cinacalcet, at levels exceeding the acceptable daily intake limit. This could pose a risk to American shoppers who rely on this medication.

• Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only.
• Manufacturer: Cipla Ltd., MIDC, Patalganga, India (for Cipla USA, Inc.).
• NDC: 69097-410-02
• Affected Lots: 4PB0526 (exp September-2026), 4PB0527 (exp September-2026), 4PB0528 (exp September-2026), 5PB0173 (exp January-2027)
• Units Affected: A big number – 113,336 bottles.
• Distribution: Nationwide in the USA

The presence of N-Nitroso Cinacalcet above the allowed limit stems from what the agency calls CGMP (Current Good Manufacturing Practice) deviations during production. CGMP helps regulate pharmaceutical manufacturing. This means manufacturing processes weren’t up to par. Nobody wants to find out their medication is potentially harmful.

What Does This Mean for You?

This is designated as a Class II recall. That means exposure to the tablets could cause temporary or medically reversible health problems. While not an immediate life-threatening danger, it's still a serious issue that shouldn't be ignored.

If you're currently taking Cinacalcet Hydrochloride Tablets from Cipla USA, don't panic, but take action. It's essential to understand what this recall means for your health and what steps you should take to address it. If you're worried, you should consult your healthcare provider.

Identifying the Recalled Cinacalcet Tablets

Figuring out if your medication is affected is the first step. Here's how to check your bottle and confirm if it's part of this product recall in the United States.

• Check the Label: Look for "Cinacalcet Hydrochloride Tablets, 30 mg" and "Manufactured for: Cipla USA, Inc." on the bottle.
• NDC Code: The NDC code should be 69097-410-02. This is a unique identifier for the medication.
• Lot Number & Expiry: Match the lot number and expiration date to the list above. For example, if your bottle says "Lot 4PB0526, exp September-2026", it's part of the recall.

These recalled tablets were distributed across the U.S., so it's likely many American shoppers may have them. If your bottle matches any of these criteria, it's important to take immediate action. Remember, not *all* Cinacalcet tablets are affected – only specific lots from Cipla USA.

What You Should Do Right Now

If you find that you have a bottle of the recalled Cinacalcet Hydrochloride Tablets, it's important to take certain steps. Here's what you should do to protect your health and well-being.

1. Stop taking the Cinacalcet Hydrochloride Tablets immediately and contact your healthcare provider to discuss alternative treatment options.
2. Contact your pharmacy to see about returning the medication for a refund or proper disposal, following their recommended procedures.
3. Report any adverse reactions or health concerns you've experienced while taking the medication to the FDA's MedWatch program.
4. Double-check any remaining medications you have to ensure they are not part of this or any other recent product recall in the United States.

It is a good idea to keep an updated list of the medications that you're taking with lot numbers and expiry dates. This will help you monitor your health and safety in the face of product recalls.

Cipla's History and Previous Recalls

It's worth noting that Cipla USA, Inc. (and its parent company, Cipla Ltd.) has experienced other recalls in the past. Looking back at the FDA's enforcement reports, reveals a few instances of similar issues.

While past recalls don't define a company, they do highlight the importance of diligent monitoring and quality control. This most recent recall of Cinacalcet Hydrochloride Tablets adds another layer of concern for those who rely on medications manufactured by Cipla. It is important to stay up to date on product recalls that can affect your health.

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: What is Cinacalcet Hydrochloride used for?

Cinacalcet Hydrochloride is a medication used to treat hyperparathyroidism, a condition where the parathyroid glands produce too much parathyroid hormone, often seen in people with chronic kidney disease.

Q: What are the potential health risks of N-Nitroso Cinacalcet?

N-Nitroso Cinacalcet is classified as a nitrosamine, and some nitrosamines are considered potential carcinogens, which means long-term exposure above acceptable levels could increase the risk of cancer.

Q: How can I report an adverse reaction to this medication?

You can report any adverse reactions to the FDA's MedWatch program either online or by phone; reporting helps the FDA monitor drug safety and identify potential problems.

Q: Where were these Cinacalcet tablets sold?

These tablets were distributed nationwide in the U.S., meaning they could be found at pharmacies across all states; they wouldn't have been sold at major retailers like Walmart, Target, Amazon, or Costco since it's a prescription medication.

Q: What does Class II recall mean?

A Class II recall indicates that exposure to the recalled product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.