Doctor Manzanilla Allergy & Decongestant Relief — Class II drug recall D-1135-2017
Terminated recall by Mid Valley Pharmaceutical, reported 2017-09-20, distributed in TX. CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination
| Recall number | D-1135-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mid Valley Pharmaceutical, Raymondville, TX, United States |
| Recall initiated | 2017-08-30 |
| Classified | 2017-09-11 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2020-05-07 |
| Distributed | TX |
| Quantity | 24 bottles |
| Reason classes | microbial contamination, cgmp |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00762558002041 |
| Lot numbers | 05/19, 23221701 |
Product
Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX 78580, UPC 7 62558 00204 1.
Reason for recall
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
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-1135-2017. 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.