Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdin
Summary
The FDA issued a Class II for Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only by Rising Pharma Holding, Inc.. Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle.
Details
Source
Drug Recall
External ID
D-0724-2026
Action Date
2026-07-29
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
Quantity Affected: 74208 units
Reason for Recall
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Distribution
Nationwide U.S.A.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 88 drug-related FDA actions this month.
Rising Pharma Holding, Inc. has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rising Pharma Holding, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rising Pharma Holding, Inc. have FDA actions?
Rising Pharma Holding, Inc. has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0724-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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