The Recall Desk
ModerateFDA (Drugs)·D-0595-2020·Announced 2019-12-18

Anazao Health Recalls Clonidine HCL Due to Fungal Contamination

Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a low-level environmental contamination (1 CFU) without reported illnesses or injuries, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL in all strengths, doses, and packaging. The recall is due to a lack of processing controls, which resulted in environmental sampling revealing 1 CFU (Colony Forming Unit) of Talaromyces rotundus, a fungus.

The affected products were filled and dispensed between August 26 and 29, 2019, and between September 27 and October 3, 2019, and remain within their expiration dates. The products were distributed nationwide in the U.S.

Consumers should stop using the recalled Clonidine HCL products and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.

The recalled product

Product
Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 31 recalled by Coast Quality Pharmacy, LLC dba Anazao Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 31 products in this recall →