FDA recall, , Moderate risk
Rising Cyproheptadine Hydrochloride Syrup
Cyproheptadine Hydrochloride Syrup has crystallized and particles floating in the bottle.
Summary by Recall Canary from the FDA notice
What happened
Rising Pharma Holding, Inc., of East Brunswick, New Jersey, recalled its Rising Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, because the medication was crystallizing and particles were floating in the bottle. The recall began July 13, 2026, and the FDA added it to its Enforcement Report on July 17, 2026, with classification on July 23, 2026.
The syrup was manufactured by Lyne Laboratories, Inc., Brockton, MA, and distributed nationwide in the U.S.A. The recall involved 74,208 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 64980-504-48
- Lot code
- CR2518
- CR2601
Recall details
- Company began the recall
- Sold in
Nationwide U.S.A.
- Company
- Rising Pharma Holding, Inc.East Brunswick, New Jersey
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99401
- Recall number
- D-0724-2026
- Quantity recalled
- 74208 units
All recalls from Rising Pharma Holding, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
