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 Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free Presence of Foreign Substance; Fiber particles. Class IIIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source Labeling: Not Elsewhere Classified; product is labeled as “Non-Corn Source” however the product is from a corn source. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereArizona and Colorado
- Medicine recall Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg CGMP Deviation: Presence of dark brown discoloration on edges of tablets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereMississippi, Ohio, Puerto Rico, Rhode Island and Tennessee
- Medicine recall Leucovorin Calcium Injection, USP 500 mg*/50 mL Crystallization: Presence of particulate matter identified as API crystallization Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Major Infants’ Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ Microbial Contamination of Non-Sterile Product. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medicine recall Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle GMP Deviation: lot not intended for commercial distribution. Class IIIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 16, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall DrKids Children’s Natural Cough Syrup English Ivy Leaf CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DrKids Himasal Natural Nasal Saline Solution CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benazepril HCl Tablets, USP 40 mg, 100 count bottles Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle Class IIIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Estradiol tablets, 0.5 mg, 100-count bottles Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc.,… Lack of Assurance of Sterility: Bag has the potential to leak. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride Injection USP 0.9% Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the… Class IIIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rifampin for Injection, USP, 600 mg/vial Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall C-ACETYLCYSTEINE OPHTH 10% SOLN Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-DEXAMETHASONE 24MG/ML INJ SOLUTION Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-METHYLCOBALAMIN 25MG/ML INJECTION PFS Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class IIFDA’s classOct 9, 2019in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedOct 9, 2019ClassClass IIStatusTerminatedWhereNew Jersey
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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