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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

Rising Pharma Carbidopa, Levodopa, Entacapone Tablets Recalled for Product Mix-Up

Agency Publication Date: October 16, 2025
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Summary

Rising Pharma Holding, Inc. is recalling 2,064 bottles of Carbidopa, Levodopa, and Entacapone tablets (25 mg/100 mg/200 mg) because some bottles may actually contain a higher strength version of the medication (37.5 mg/150 mg/200 mg). The recall was initiated after a complaint that a sealed bottle of the lower strength medication contained the higher strength film-coated tablets. These medications are used to treat Parkinson's disease, and taking a higher dose than prescribed could lead to serious health complications. Consumers should contact their healthcare provider or pharmacist immediately to discuss their medication.

Risk

Patients may inadvertently take a higher dose of Carbidopa, Levodopa, and Entacapone than prescribed, which can lead to increased side effects or toxicity associated with these medications.

What You Should Do

  1. Check your medication bottle for NDC 16571-691-01 and Lot CS25070 with an expiration date of 03/31/2027.
  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) or visit www.fda.gov/safety/recalls 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: Carbidopa, Levodopa, Entacapone Tablets (100-count bottle)
Variants: 25 mg/100 mg/200 mg, Film-coated, Rx Only
Lot Numbers:
CS25070 (Exp 03/31/2027)
NDC:
16571-691-01

Recall #: D-0029-2026. Manufactured by Suven Pharmaceuticals Limited in India for Rising Pharma Holdings, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97768
Status: Active
Manufacturer: Rising Pharma Holding, Inc.
Sold By: Retail pharmacies
Manufactured In: India
Units Affected: 2,064 100-count 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.