CLASS II ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalled
Rising Pharma Holding is recalling Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, distributed nationwide in the US. The recall was initiated on 7 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0029-2026
- FDA event ID
- 97768
- Recalling firm
- Rising Pharma Holding, East Brunswick, NJ
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Oct 2025
- FDA classified
- 16 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 7 Oct 2025 | Recall initiated by company | |
| 16 Oct 2025 | Classified by FDA | +9 days |
| 22 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalled?
Yes. Rising Pharma Holding recalled Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg on 7 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0029-2026.
Why was it recalled?
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).
Which lots are affected?
Lot # CS25070, exp. date 03/31/2027
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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