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 Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy,… Lack of sterility assurance. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin for Oral Suspension USP, 125 mg per 5 mL Subpotent Product: assay results for Amoxicillin were below the specification limits. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95… Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. Class IIIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2019ClassClass IIIStatusTerminatedWhereNationwide, and West Virginia named
- Medicine recall Losartan 50mg Tablet, 30 count each blister card. CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Biotin 10 mg/mL Injection, 30 mL vial Failed pH Specification: product does not meet pH label claim. Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film… CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API). Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Clonidine HCL Injection, 1000 mcg/10mL Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as “500 mcg Clonidine Hydrochloride” rather than the correct… Class IIIFDA’s classApr 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Professional Compounding Pharmacy, 996… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall ACETYL-L-CYSTEINE 10% P.F Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml injectable, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml, (c) 6ml, penile injection,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PGE1 40 MCG/ML* INJECTABLE Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile injection, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6ml, (c) 9ml (d) 10ml, Professional… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Professional Compounding Pharmacy,… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
- Medicine recall PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.5ml, Professional Compounding… Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection. Class IIFDA’s classApr 17, 2019in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 17, 2019ClassClass IIStatusTerminatedWhereOregon
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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