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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Strides Pharma Cinacalcet Tablets Recalled for Failed Dissolution

Agency Publication Date: July 30, 2025
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Summary

Strides Pharma, Inc. is recalling 6,672 bottles of Cinacalcet (cinacalcet) Tablets 90 mg (30-count bottles) because the medication failed dissolution specifications. This means the tablets may not break down and dissolve as intended once ingested, which can affect how the medicine is absorbed by the body. The affected product is a prescription-only medication and was distributed nationwide within the United States.

Risk

If the tablets do not dissolve properly, patients may not receive the full or consistent dose of the medication. This could lead to the treatment being less effective than required for the patient's condition.

What You Should Do

  1. This recall affects 30-count bottles of Strides Pharma Cinacalcet Tablets 90 mg with NDC 64380-885-04, lot number 7715893A, and an expiration date of 12/31/2027.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cinacalcet Tablets 90 mg (30-count bottles)
Variants: 90 mg, 30-count bottles, Rx only
Lot Numbers:
7715893A (Exp. 12/31/2027)
NDC:
64380-885-04

Manufactured by Strides Pharma Science Ltd. Puducherry, India; Distributed by Strides Pharma Inc. East Brunswick, NJ 08816.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97215
Status: Active
Manufacturer: Strides Pharma, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 6,672 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.