Browse Drug Recalls

32 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 32 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 32 FDA drug recalls.

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DateProductReasonClassFirm
Apr 24, 2024 Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... Presence of Foreign Substance; Broken metal piece found embedded in tablet. Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses a... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL P... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packa... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL and Baclofen in all strengths, all doses and all packaging, Ana... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all s... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all dose... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all s... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, a... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoo... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses a... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, A... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 571... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all st... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all st... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packag... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all pack... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, al... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fent... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.