FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Rising Cyproheptadine Hydrochloride Syrup recalled for crystalline precipitate
What this means
Rising Pharma's Cyproheptadine Hydrochloride Syrup (2 mg/5 mL, 473 mL bottles) is being recalled because the medication is crystallizing and forming particles that float in the bottle. This affects specific batches distributed nationwide. No injuries have been reported.
- Check if you have an affected batch (CR2518, CR2601, CR2602, CR2603, CR2604, or CR2605).
- Do not use medication from affected batches.
- Contact your pharmacist or prescriber for a replacement or alternative medication.
The agency's original wording
Hazard
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide U.S.A.
Affected count
74208 units
Manufactured in
2 Tower Center Blvd Ste 1401, N/A, East Brunswick, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0724-2026Want us to check the next one for you?
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