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 Losartan Potassium Tablets USP 25 mg 1000 count bottle 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 classMay 29, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, Pennsylvania, Tennessee and Texas
- Medicine recall Losartan Potassium Tablets USP 100 mg 90 count bottle 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 classMay 29, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, Pennsylvania, Tennessee and Texas
- Medicine recall Losartan Potassium Tablets USP 100 mg 1000 count bottle 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 classMay 29, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, Pennsylvania, Tennessee and Texas
- Medicine recall Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets 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 classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 100 mg 90 film coated tablets 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 classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 50 mg 90 film coated tablets 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 classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 100 mg 1000 film coated tablets 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 classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 25 mg 90 film coated tablets 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 classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle Labeling: Label mix-up. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle Labeling: Label mix-up. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each Labeling: Not Elsewhere Classified. Class IIFDA’s classMay 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Promacta (eltrombopag) 12.5 mg for Oral Suspension Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 29, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 29, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan… Class IIIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tab 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 classMay 22, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia and Indiana
- Medicine recall Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Children’s Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Children’s Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 Pre-measured Single-Use Vials 0.17… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Children’s Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Children’s Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measured Single-Use 0.17 fl CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Single-Use Vials, Drug Free CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Children’s Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin,… CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classMay 22, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Tablets, USP, 400 mg, 100 count bottles Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 6.25 mg, 500 count bottles Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of… Class IIFDA’s classMay 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FENTANYL Transdermal System, 12 mcg/h, five Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 50 mg 50 tablets 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 classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 25 mg 50 tablets 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 classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile… Sub-potency Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione 200mg/mL inj Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose… Lack of assurance of sterility for injectables and solutions intended to be sterile. Class IIFDA’s classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API) Class IIFDA’s classMay 8, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 8, 2019ClassClass IIStatusOngoingWhereArizona and Tennessee
- Medicine recall Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per… 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 classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per… 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 classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 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 classMay 8, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2019ClassClass IIStatusOngoingWhereNationwide, 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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