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 7, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Little Remedies New Baby Essentials Kit Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit. Class IIFDA’s classMar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levoleucovorin Injection, 250 mg/25 mL Presence of Particulate Matter: particulate matter identified as copper salts FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 20, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only,… Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereArizona, California, Michigan and New York
- Medicine recall BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90… Failed Dissolution Specifications; 9-monthstability timepoint Class IIIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 13, 2019ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl Cross Contamination: Presence of IPA in finished product. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Maeng Da Kratom MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 13, 2019ClassClass IStatusTerminatedWhereCalifornia, Nebraska, Oregon and Washington
- Medicine recall White Vein Kratom MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 13, 2019ClassClass IStatusTerminatedWhereCalifornia, Nebraska, Oregon and Washington
- Medicine recall White Vein Kratom MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 13, 2019ClassClass IStatusTerminatedWhereCalifornia, Nebraska, Oregon and Washington
- Medicine recall Maeng Da Kratom MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 13, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 13, 2019ClassClass IStatusTerminatedWhereCalifornia, Nebraska, Oregon and Washington
- Medicine recall Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash… Class IIIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 13, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. Class IIFDA’s classMar 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities. Class IIIFDA’s classMar 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution,… Labeling: Incorrect expiration date. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedFeb 27, 2019ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately… Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately… Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately… Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c)… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-count bottle (NDC:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90) CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC:… CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Diltiazem HCl Extended-Release Capsules, USP 180mg Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle Failed Dissolution Specifications: Out of specification results observed for high dissolution. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe Lack of assurance of sterility. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP 1000 mL flexible container CGMP Deviations Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold. Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ Failed Stability Specification: out of specification results for Sodium Perborate Class IIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ciclopirox shampoo 1%,120 mL bottle Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lovastatin Tablets USP, 40 mg CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mometasone Furoate Cream, 0.1%, 45 g tube Labeling: Not Elsewhere Classified. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60)… Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Temozolomide Capsules, 5 mg Failed dissolution specifications Class IIIFDA’s classFeb 27, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine Ophthalmic Solution, 100mg/ml, 10% Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 6 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/… Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin D3 50,000iu/mL, injection 5 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide… Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin lyophilized 50,000 mcg Injection Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin lyophilized, 10,000 mcg Injection Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione Injection, 200 mg/mL, 10 mL Lack of sterility assurance. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
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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