Rising Pharma Holdings recalled 2,064 bottles of Carbidopa, Levodopa and Entacapone tablets distributed nationwide in the United States. Sealed bottles labeled 25 mg/100 mg/200 mg contained 37.5 mg/150 mg/200 mg instead. Healthcare providers and patients should stop using immediately and await recall letter guidance.
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).
Consumers and healthcare providers should stop using this product immediately. Contact Rising Pharma Holding, Inc. or your healthcare provider for guidance. Notification method: Letter
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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.
A product mix-up that changes tablet strength can lead to overdosing or underdosing, potentially causing adverse reactions or reduced symptom control.
This recall is not described as part of a broader industry pattern.
Patients may experience unexpected side effects or loss of disease control. The recall could require provider intervention and possible medication changes.
NDC, lot number and expiration are on the bottle label and carton.
Replacement or refund guidance will be provided in the recall letter; processing typically 4-8 weeks.
Keep the recall letter, bottle, and any prescription records; photograph labels and packaging for records.
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
No injuries or incidents have been reported.
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