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 5, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Quinacrine Dihydrochloride Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals,… Failed Impurities/Degradation Specifications Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive,… cGMP Deviations: Potential glass contamination Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West… cGMP Deviations: Potential glass contamination Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West… cGMP Deviations: Potential glass contamination Class IIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PRE-TAT (lidocaine) 3 Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PRE-TAT (lidocaine) 3 Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Superior Pain & Itch Relief (lidocaine) Cream, 4% Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4% Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soothing Sore Relief (lidocaine) Cream, 4% Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soothing Sore Relief (lidocaine) Liquid Gel, 4% Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anagrelide Capsules, USP, 0.5 mg, 100-count bottle Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing. Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle Failed Impurities/Degradation Specificattion Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member’s Mark Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets USP, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets USP, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine HCL Tablets USP, 180 mg, 500’s BRITE STOCK Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR Failed Impurities/Degradation Specifications Class IIFDA’s classSep 25, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamivudine Tablets, USP, 150 mg, 30 Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description… Class IIIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle Failed Impurities/Degradation Specifications:OOS for unknown impurity. Class IIIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only Lack of assurance of sterility. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 18, 2019ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only Lack of assurance of sterility. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 18, 2019ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg Class IIIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bacteriostatic Water for Injection, USP, 30 mL vials Lack of Assurance of Sterility Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed Lack of Processing Controls: Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles Lack of Processing Controls: Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles Lack of Processing Controls: Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle Failed Stability Specifications. Class IIFDA’s classSep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use… Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 18, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Eptifibatide Injection, 75 mg/100 mL Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid. Class IIIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Eptifibatide Injection, 75 mg/100 mL Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of… Class IIIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Eptifibatide Injection, a) 20 mg/10 mL Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid. Class IIIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Simvastatin Tablets, USP 40 mg Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B Class IIIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall RELPAX (eletriptan HBr) tablets, 40 mg Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial Labeling: Not Elsewhere Classified. Class IIFDA’s classSep 4, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2… CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%)… CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Assorted IRC Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, 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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