RecallRadar

FDA Drug recall D-0240-2015

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605,…

On 2014-11-12 the FDA classified a Class II recall of Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605,… by Pharmaceutical Associates, citing failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0240-2015
ClassificationClass II
Statusterminated
Initiated2014-10-16
Published2014-11-12
Last updated2026-09-13 11:51 UTC
CompanyPharmaceutical Associates
DistributionUS

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

Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.

Identifiers

code_infoLot 3H43, Exp. 02/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0240-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.