Cyproheptadine HCl Syrup — Class II drug recall D-0240-2015
Terminated recall by Pharmaceutical Associates Inc, reported 2014-11-12, distributed nationwide. Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the
| Recall number | D-0240-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharmaceutical Associates Inc, Greenville, SC, United States |
| Recall initiated | 2014-10-16 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2017-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 9,640 units |
| Reason classes | specification failure |
| NDC | 00121-4788-10 |
| Lot numbers | 02/15, 3H43 |
Product
Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
Reason for recall
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0240-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.