Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution Recalled by Pharmaceutical Associates Inc Due to Failed Impurities/Degradation Specifications : Out-of-specification result for an...

Date: October 16, 2014
Company: Pharmaceutical Associates Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pharmaceutical Associates Inc directly.

Affected Products

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

Quantity: 9,640 unit dose cups

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pharmaceutical Associates Inc

Pharmaceutical Associates Inc has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report