CLASS II ONGOING Drug recall · Reported 29 Jul 2026 · FDA Enforcement Report
Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalled
Rising Pharma Holding is recalling Rising, Cyproheptadine Hydrochloride Syrup, 2mg, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0724-2026
- FDA event ID
- 99401
- Recalling firm
- Rising Pharma Holding, East Brunswick, NJ
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2026
- FDA classified
- 23 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 13 Jul 2026 | Recall initiated by company | |
| 23 Jul 2026 | Classified by FDA | +10 days |
| 29 Jul 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Product as listed by the FDA
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.
Where it was distributed
Nationwide U.S.A.
Questions about this recall
Why was it recalled?
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Which lots are affected?
Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.
Where was it sold?
Nationwide U.S.A.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
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Other Cyproheptadine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg recalled | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS III | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg recalled | Lyne Laboratories | Potency & Assay | NJ |
| Drug | CLASS II | Cyproheptadine HCL Tablet, 4 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |