Robafen DM — Class II drug recall D-1410-2019
Terminated recall by Preferred Pharmaceuticals, Inc, reported 2019-06-26, distributed in CA, FL. CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii
| Recall number | D-1410-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc, Anaheim, CA, United States |
| Recall initiated | 2019-06-10 |
| Classified | 2019-06-20 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2023-04-03 |
| Distributed | CA, FL |
| Quantity | 192 |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 68788-0841-01 |
| Lot numbers | 10021812, J0218L, L2718D |
| Expiration dates | 2020-02, 2020-07 |
Product
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
Reason for recall
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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-1410-2019. 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.