Anazao Health Recalls Baclofen, Clonidine, and Morphine Sulfate Due to Fungal Contamination
Anazao Health is recalling Baclofen, Clonidine HCL, and Morphine Sulfate products due to the detection of Talaromyces rotundus fungi during environmental sampling.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant hazards like fungal contamination in pharmaceutical products, even without explicit hospitalization reports in the provided text.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, doses, and packaging. The recall was initiated because environmental sampling revealed the presence of Talaromyces rotundus, a type of fungi, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and 29, 2019, and from September 27 through October 3, 2019. The recall covers all lots remaining within their expiration dates. The products were distributed nationwide in the United States.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Baclofen and Clonidine HCL and Morphine Sulfate 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 — Pharmaceutical
- Hazard
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
- ModerateAnazao Health Recalls Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL
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
- SevereFDA Recalls Morphine, Clonidine, and Baclofen Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- CriticalFDA Recalls Compulsin Homeopathic OTC Medicine Due to Microbial Contamination
FDA (Drugs) · 2018-09-19
- SevereFDA Recalls Hydromorphone and Baclofen Intrathecal Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereFDA Recalls Intrathecal Solution Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereFranck's Lab Recalls Sterile Hydromorphone/Clonidine Intrathecal Drugs
FDA (Drugs) · 2012-08-22