Quick Facts at a Glance
- Recall Date
- October 7, 2025
- Hazard Level
- HIGH
- Brands
- Rising Pharma Holdings, Carbidopa, Levodopa and Entacapone
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Rising Pharma Holdings, Carbidopa, Levodopa and Entacapone
- Product type
- Carbidopa, Levodopa and Entacapone Tablets
- Model numbers
- Lot CS25070, exp. date 03/31/2027
- UPC codes
- 16571-689, 16571-690, 16571-691, 16571-692, 16571-693, 16571-694, 16571-689-01, 16571-690-01 +4 more
- Sizes
- 100-count bottle
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 7, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Carbidopa/Levodopa/Entacapone is a fixed-dose combination used to manage Parkinson’s disease symptoms by replenishing dopamine. The triple therapy requires precise dosing to balance efficacy and side effects.
Why This Is Dangerous
A product mix-up that changes tablet strength can lead to overdosing or underdosing, potentially causing adverse reactions or reduced symptom control.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients may experience unexpected side effects or loss of disease control. The recall could require provider intervention and possible medication changes.
Practical Guidance
How to identify if yours is affected
- Verify NDC 16571-691-01 on the bottle.
- Check Lot CS25070 and expiration date 03/31/2027.
- Confirm bottle size is 100-count.
Where to find product info
NDC, lot number and expiration are on the bottle label and carton.
What timeline to expect
Replacement or refund guidance will be provided in the recall letter; processing typically 4-8 weeks.
If the manufacturer is unresponsive
- Document all communications with Rising Pharma and your provider.
- File a consumer complaint with FDA if there is no progress.
How to prevent similar issues
- Always verify NDC and strength before dispensing or taking a medication.
- Ask pharmacists for confirmation if there is any packaging discrepancy.
- Keep a personal medicine list with current dosages and cross-check during supply changes.
Documentation advice
Keep the recall letter, bottle, and any prescription records; photograph labels and packaging for records.
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Product Details
NDC: 16571-691-01 Lot #: CS25070 Exp: 03/31/2027 Size: 100-count bottle Sold: Nationwide in the USA Manufacturer: Suven Pharmaceuticals Limited, Pashamylaram, Telangana 205307, India Distributed for: Rising Pharma Holdings, East Brunswick, NJ 08816 Quantity: 2,064 bottles Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 2064 bottles recalled nationwide
- Mislabeled strength 25 mg/100 mg/200 mg vs actual 37.5 mg/150 mg/200 mg
- Class II recall, HIGH hazard level, Recall date 2025-10-07
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Safety Guide
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