Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Gaia… Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial Presence of Particulate Matter: identified as glass and silicone material FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL Superpotent Drug: High out of specification assay value results for potency. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL Superpotent Drug: High out of specification assay value results for potency. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL 20mg PELLET, 1-count 3ml amber vial Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 1 mg/mL (preservative free Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl (as citrate) 10 mcg/mL Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCL 1 mg/mL Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate 4 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate 8 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine Bitartrate 16 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 10 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 40 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 20 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 50 mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCL 80mg Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage. Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of… Class IIIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall eb5 Skincare that Works Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity Class IIFDA’s classJul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes… Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes… Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall fentanyl Citrate USP 5 mcg Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated on the label. Class IIFDA’s classJul 4, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 4, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.45% Sodium Chloride Injection, USP, 100 mL bag Lack of assurance of sterility: Bags have potential to leak. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 250 mL bag Lack of assurance of sterility: Bags have potential to leak. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.