July 2026 FDA Recall Cyproheptadine Hydrochloride by Rising Pharma Holding, Inc.
D-0724-2026 - Presence of Precipitate
This Class II drug recall was voluntarily initiated by Rising Pharma Holding, Inc. on July 13, 2026 for the product Cyproheptadine Hydrochloride. The FDA reported the reason for recall as presence of precipitate. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0724-2026
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
07-13-2026
07-29-2026
74208 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Rising Pharma Holding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide U.S.A.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.
Batch or Lot Expiration Information
Lot# Lots:
Lot# CR2518, Exp. 11/2027
Lot# CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
