Medicines, 2018
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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 TravelEase, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Party Relief, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arnica Power, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Snore Soother, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Stress Relief, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PMS Support, Homeopathic Oral Spray, 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Life Detoxer Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ImmunoBooster, Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Body Skin Tonic, Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acne Tonic Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Body Balance, Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diet Power, Homeopathic Oral Spray 1.38 fl CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Bulk Active Pharmaceutical Ingredient. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles Failed Dissolution Specifications: OOS resultsduring routine stability testing Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of… Lack of assurance of sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston,… Lack of assurance of sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone Lack of assurance of sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 25 mg added to NS 250 mL Bag Lack of assurance of sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 30 mg added to NS 250 mL Bag Lack of assurance of sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetylcysteine Injection 10 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate 1% Eyewash Oph Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate 2.5% a) 250 mL 25 mg/mL Lack of Assurance of Sterility Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Reconstitued 6000 IU Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 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.”
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