Medicines, 2019
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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 5, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Phenylephrine HCl 1.5% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 1.5% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYephrine HCl Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYephrine HCl Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYephrine HCl Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Polidocanol 5%, 500 mg / 10 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine… Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine… Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate 9 mg/ 3 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Citrate 40 mg/mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCCinylcholine Chloride (PF), 100 mg / 5 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCCinylcholine Chloride (PF), 140 mg/7 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCCinylcholine Chloride (PF), 200 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 10 B Lyophilized, Vial, For IM Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 5 B, 30 mL Vial For IM Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 9 Lyophilized, Vial For IM Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin 9A/B Lyophilized, Vial For IM Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single… Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL Lack of Assurance of Sterility Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial Labeling: Not Elsewhere Classified. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP 50mg, 1000 tablets per 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 classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per 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 classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per 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 classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per 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 classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ethosuximide capsules, USP, 250 mg, 100-count bottle Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Labeling: Incorrect or Missing Lot and/or Exp Date. Class IIIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 2, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets Failed Dissolution Specifications: Class IIIFDA’s classOct 2, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 2, 2019ClassClass IIIStatusTerminatedWhereNo state 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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