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.

Robafen DM Recalled by Preferred Pharmaceuticals, Inc Due to CGMP Deviations: Potential product contamination with Burkholderia cepacia...

Date: June 10, 2019
Company: Preferred Pharmaceuticals, 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 Preferred Pharmaceuticals, Inc directly.

Affected Products

Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

Quantity: 192 4 oz bottles

Why Was This Recalled?

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Where Was This Sold?

This product was distributed to 2 states: CA, FL

Affected (2 states)Not affected

About Preferred Pharmaceuticals, Inc

Preferred Pharmaceuticals, Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

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