FDA Recall D-0029-2026

Rising Pharma Holding, Inc. · East Brunswick, NJ

Class II Ongoing 219 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot # CS25070, exp. date 03/31/2027

Quantity: 2,064 100-count bottles

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).

Recall record

Recall number: D-0029-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-10-07
Classified by FDA Center: 2025-10-16
FDA published: 2025-10-22
Recalling firm: Rising Pharma Holding, Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): CARBIDOPA, LEVODOPA AND ENTACAPONE
Generic name(s): CARBIDOPA, LEVODOPA AND ENTACAPONE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 16571-689, 16571-690, 16571-691, 16571-692, 16571-693, 16571-694
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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