Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION Recalled by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals Due to Failed Stability Specifications: Out of Specification results obtained...

Date: October 21, 2015
Company: Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
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 Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals directly.

Affected Products

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.

Quantity: 61,146 Bottles

Why Was This Recalled?

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals has 5 total recalls tracked by RecallDetector.

Related Recalls

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