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Stop using now Drug recall · FDA · Published September 3, 2019

Anazao Health Recalls Hydromorphone, Baclofen & Clonidine Due to Fungal Contamination

Anazao Health recalls specific lots of Hydromorphone HCL, Baclofen, and Clonidine HCL due to lack of processing controls and fungal contamination.

🇺🇸 FDA recall #D-0590-2020DrugAnazao Health ›
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Recalling firmCoast Quality Pharmacy, LLC dba Anazao Health5710 Hoover Blvd · Tampa, FL 33634-5339
✎ GovInfoNow plain-language explainer

Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL, Baclofen, and Clonidine HCL in all strengths and packaging. The recall was initiated because environmental sampling revealed a lack of processing controls that allowed the fungi Talaromyces rotundus to contaminate the products. This affects lots filled between August 26-29, 2019, and September 27 - October 3, 2019. Read more at govinfonow.com/recall/38026-anazao-health-recalls-hydromorphone-baclofen-clonidine-due-to-fungal-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/38026-anazao-health-recalls-hydromorphone-baclofen-clonidine-due-to-fungal-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0590-2020

Cite this page

“Anazao Health Recalls Hydromorphone, Baclofen & Clonidine Due to Fungal Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38026-anazao-health-recalls-hydromorphone-baclofen-clonidine-due-to-fungal-contamination. Based on FDA recall #D-0590-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0590-2020%22&limit=1).

The FDA announced on September 3, 2019, that Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Baclofen and Clonidine HCL due to a lack of processing controls. Environmental sampling revealed the presence of Talaromyces rotundus fungi in the products.

How to tell if you have it

  • Brand: Anazao Health
  • Product: Hydromorphone HCL and Baclofen and Clonidine HCL
  • Packaging: AnazaoHealth 5710
  • Lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019

The hazard

The recall is due to a lack of processing controls. Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Context

GovInfoNow's records show Coast Quality Pharmacy, LLC dba Anazao Health has one other recall on record since 2024-04-24. On 2024-04-24, the brand recalled Progesterone 200mg Tablets due to broken metal in tablets. Other recent recalls of similar products include Golden State Medical Recalls Primidone Tablets Due to Contamination (2026-04-27), Amneal Recalls Primidone Tablets Due to Cross-Contamination Risk (2026-06-03), and ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance (2026-06-02).

How to tell if you have this one

Check if you have Hydromorphone HCL, Baclofen, and Clonidine HCL dispensed by Anazao Health. The affected lots were filled on 08/26-29/2019 and 09/27/2019 through 10/03/2019. The product is identified as AnazaoHealth 5710.

  • Brand
    Anazao Health
  • Category
    Drug
FDA recall event · 31 products

All 31 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in the U.S.
Recall numberProduct, codes & lotsQuantity
D-0578-2020Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0579-2020Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed 09/24-26/2019 remaining within expiry.17 vials
D-0580-2020Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0581-2020Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0582-2020Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0583-2020Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0584-2020Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0585-2020Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0586-2020Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0587-2020Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0588-2020Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0589-2020Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0590-2020Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0591-2020Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0592-2020Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0593-2020Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0594-2020Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.Unknown
D-0595-2020Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0596-2020Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0597-2020Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0598-2020Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0599-2020Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0600-2020Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0601-2020Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0602-2020Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0603-2020Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0604-2020Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0605-2020Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0606-2020Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0607-2020Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
D-0608-2020Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.; All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.Unknown
Based on the official FDA remedy

What to do — step by step

  1. Stop using the medication

    Do not consume any remaining doses of the recalled Hydromorphone HCL, Baclofen, and Clonidine HCL products.

  2. Contact your pharmacy

    Reach out to the pharmacy where you received the medication to report the issue and discuss next steps for replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the U.S.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Sep 3, 201912. FDA classified it Class II: Dec 6, 201923. Published in FDA’s Enforcement Report: Dec 18, 201934. FDA terminated the recall: Dec 1, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Where were these products distributed?

The affected products were distributed nationwide within the United States.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0590-2020 (September 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0590-2020 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA