Cyproheptadine Hydrochloride Syrup Recall Due to Precipitate
Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a physical precipitate in the medication, which is a quality issue rather than a high-risk pathogen or allergen mislabeling.
Plain-English summary
Rising Pharma Holding, Inc. is recalling cyproheptadine hydrochloride syrup, 2mg/5 mL, 473 mL (one pint), NDC 64980-504-48, due to the presence of precipitate in the medication. The issue involves crystallization and particles floating in the bottle.
The recall affects 742,080 units distributed nationwide in the U.S.A. The affected lots include Batch #CR2518 (Exp. 11/2027), Batch #CR2601 (Exp. 12/2027), CR2602 and CR2603 (Exp. 01/2028), and CR2604 and CR2605 (Exp. 02/2028).
Consumers who have this medication should check the lot number and expiration date on their bottle. If the product is from an affected lot, contact the pharmacy or healthcare provider for return or replacement instructions. Do not use the medication if precipitate is visible.
The manufacturer identified the issue during routine testing and has notified distributors and retailers. This is a Class II recall, meaning use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE HYDROCHLORIDE)
- Brand
- CYPROHEPTADINE HYDROCHLORIDE
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug — Oral Liquid Antihistamine
- Affected units
- 74,208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lots: Batch # CR2518
- Exp. 11/2027
- Batch # CR2601
- Exp. 12/2027
- CR2602
- CR2603
- Exp. 01/2028
- CR2604
- CR2605
- Exp. 02/2028.
UPCs (1)
- 0364980504485
Distribution
Distributed nationwide across the United States.
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