Medicines, 2019
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2,152 medicine recalls FDA’s Enforcement Report published in 2019, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers Failed Impurities/Degradation Specifications Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VCF Vaginal Contraceptive Foam, a) can, 13 applications per can Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Memantine Hydrochloride Extended-release Capsules, 28mg Failed Dissolution Specifications: High out of specification result observed at stability studies. Class IIIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Oral Solution 100mg/mL, 473 mL Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gabapentin Capsules, USP 100 mg Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles.. Class IIFDA’s classDec 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 1 g* per vial Discoloration: Product complaints of discoloration after reconstitution of vials. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle Presence of Foreign Substance: Presence of a foreign object in a single tablet. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 25% Dextrose Injection, USP 2.5 grams Labeling: Incorrect or Missing Lot and/or expiration date. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging,… Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Memorial Central TPN Lack of sterility assurance. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medicine recall Trisodium Citrate 0.5% CRRT SOLUTION Lack of sterility assurance. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medicine recall Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC… CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC… CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranitidine Syrup Oral Solution 15 mg/mL 6 CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranitidine Tablets, USP 150 mg, 1000-count bottles CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranitidine Tablets, USP 300 mg, 250-count bottles CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class IIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC… CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classDec 18, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 18, 2019ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94) Defective delivery system; product is not foaming or is coming out as liquid. Class IIIFDA’s classDec 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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