Anazao Health Recalls Clonidine and Baclofen Due to Fungal Contamination
Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 does not report any illnesses, injuries, or hospitalizations, and the contamination is described as a single CFU detected in environmental sampling, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Baclofen in all strengths, doses, and packaging. The recall is due to a lack of processing controls, as environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
The affected products were filled and dispensed between 08/26-29/2019 and 09/27/2019 through 10/03/2019, provided they remain within their expiry date. The products were distributed nationwide in the U.S.
Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Pharmacy Compounded
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 →Related recalls
Same manufacturer · Coast Quality Pharmacy, LLC dba Anazao Health
See all →- HighProgesterone 200 mg compounded tablets recalled for embedded metal fragments
FDA (Drugs) · 2024-07-03
- ModerateAnazao Health Recalls Clonidine and Hydromorphone Due to Fungal Contamination
FDA (Drugs) · 2019-12-18
- SevereAnazao Health Recalls Hydromorphone, Baclofen, and Clonidine Combination Drugs
FDA (Drugs) · 2019-12-18
- SevereAnazao Health Recalls Compounded Sufentanil Syringes Due to Fungal Contamination
FDA (Drugs) · 2019-12-18
- SevereAnazao Health Recalls Baclofen, Clonidine, and Morphine Sulfate Due to Fungal Contamination
FDA (Drugs) · 2019-12-18
Same hazard · fungal contamination
See all →- CriticalMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- SevereMedline Convenience Kits Recalled for Fungal Contamination Risk
FDA (Devices) · 2026-09-23
- CriticalMedline Convenience Kits Recalled for Potential Fungal Contamination
FDA (Devices) · 2026-09-23
- CriticalMedline Recalls Blood and Urine Collection Kits Due to Fungal Contamination
FDA (Devices) · 2026-09-23
Similar recalls
- SevereFDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereZydus Recalls Anastrozole Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- ModerateFungal Fusion antifungal kit recalled for discontinued stability testing
FDA (Drugs) · 2026-07-08
- ModerateReliable Drug Recalls Fluconazole Products Due to Processing Control Issues
FDA (Drugs) · 2016-07-13
- ModerateHerbal Doctor Remedies Recalls Fungo Off Capsules for Manufacturing Violations
FDA (Drugs) · 2019-08-14
- ModerateHealth One Pharmaceuticals Recalls Chlorella with Lactobacillus Supplements
FDA (Food) · 2015-04-08