Cyproheptadine Hydrochloride Syrup
FDA Recall NDC 64980-504
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cyproheptadine Hydrochloride (NDC 64980-504). A significant event, classified as Class II, was initiated on Jul 13, 2026 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Presence of Precipitate: medication was crystallizing and particles floating in the bottle"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Jul 13, 2026
Jul 29, 2026
74208 units
Recall Profile & Regulatory Data
Event ID
99401
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Rising Pharma Holding, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S.A.
Product Description
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.
Affected Packages Involved in this Recall
64980-504-48Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
