Class II · Moderate risk
Cyproheptadine Hydrochloride Syrup Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Rising (Cyproheptadine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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.
Affected NDC
64980-0504-48
Compare with the code on your package — it is the most precise check available.
Drug: Cyproheptadine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cyproheptadine Hydrochloride NDC 64980-0504 |
2 mg/5mL | Syrup Oral |
Rising Pharma Holdings, Inc. | Rx |
- Recalling firm
- Rising Pharma Holding, Inc.
- NDC code
- 64980-504-48
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0724-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Cyproheptadine recalls
See all
Class III · Low risk
Cyproheptadine Hydrochloride Syrup
Subpotency: product assayed and found OOS for cyproheptadine
Class II · Moderate risk
Cyproheptadine HCl Syrup
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Class II · Moderate risk
CYPROHEPTADINE HCL Tablet
Labeling:Label Mixup; CYPROHEPTADINE HCL Tablet, 4 mg may be potentially mislabeled as ACARBOSE, Tablet, 25 mg, NDC 00054014025, Pedigree: W003673, EXP: 6/25/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W003323, EXP: 6/18/2014.
Other recalls by Rising Pharma Holding, Inc.
All 2026 recalls
Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class II · Moderate risk
Carbidopa
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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