The Recall Desk
HighFDA (Drugs)·D-0029-2026·Announced 2025-10-22

[pending] CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)

Pending LLM rewrite. Source: FDA_DRUG D-0029-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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).

The recalled product

Product
CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
Brand
CARBIDOPA, LEVODOPA AND ENTACAPONE
Manufacturer
Rising Pharma Holding, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # CS25070
  • exp. date 03/31/2027

UPCs (5)

  • 0316571690015
  • 0316571694013
  • 0316571692019
  • 0316571691012
  • 0316571693016

Distribution

Distributed nationwide across the United States.