Medicines, 2019
Shortlist up to four to read them side by side.
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 6, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Compounding Pharmacy, 996 NW Circle… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Professional Compounding Pharmacy,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall Indian Herb Paste (a dietary supplement) Ingredients: Galangal, Indian Paint, Yellow Dock & Licorice in an… Unapproved new drug Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Life-Line tm Catalytic Activated Energy Water, 1 gallon container, McDaniel Life-Line LLC 1775 US Hwy 385… Unapproved new drug Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list “natural lemon flavor” as an ingredient Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b) 1000-count (NDC: 13668-113-10),… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count (NDC: 13668-409-30), b) 90-count (NDC: 13668-409-90), c)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10),… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/12.5mg, a) 30-count (NDC: 13668-117-30), b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b)… CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 17, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle Failed Impurities/Degradation Specifications; 18 month long term stability study. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWhereArizona and Colorado
- Medicine recall Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereMassachusetts, New York and Wyoming
- Medicine recall Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereMassachusetts, New York and Wyoming
- Medicine recall Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LEOPARD Miracle Honey Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl Injection, USP 1 % 50 mg/5 mL Presence of Particulate Matter: One vial was found to contain a hair. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 17, 2019ClassClass IStatusTerminatedWhereNorth Carolina and New Mexico
- Medicine recall Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Clindamycin Injection, USP, 300 mg/ 2 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Clindamycin Injection, USP, 600 mg/ 4 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Clindamycin Injection, USP, 900 mg/6 mL Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time… Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq Presence of Particulate Matter; glass particulates FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 10, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 10, 2019ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereArizona, Indiana and Tennessee
- Medicine recall Cefuroxime 10mg/mL INJ 0.5 mg, SDV Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API. Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepinephrine 16 mg added to 0.9% Sodium Chloride (PF), 16 mg / 250 mL, 250 mL IV bag Labeling: Label mix-up Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NORepinephrine 4 mg added to 5% Dextrose 250 mL Bag (PF), 4 mg / 250 mL, 250 mL IV bag Labeling: Label mix-up Class IIFDA’s classApr 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. Class IIIFDA’s classApr 10, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 10, 2019ClassClass IIIStatusTerminatedWhereArkansas and Mississippi
- Medicine recall Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles cGMP Deviations Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Fayosim (levonorgestrel and ethinyl estradiol) tablets USP Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total… Class IIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 3, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking. Class IIIFDA’s classApr 3, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 3, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
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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