Medicines, 2021
Shortlist up to four to read them side by side.
1,016 medicine recalls FDA’s Enforcement Report published in 2021, 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.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Epoprostenol Sodium for Injection, 0.5 mg/vial Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoclopramide Injection USP, 10 mg/2 mL Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Toposar (etoposide injection USP), 1 gram/50 mL Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Epoprostenol Sodium for Injection, 1.5 mg/vial Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Leucovorin Calcium for Injection, USP, 350 mg/vial Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cisatracurium Besylate Injection, USP, 10mg per 5mL Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 3, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Imatinib Mesylate Tablets 100mg Failed Dissolution Specifications Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial Lack of Assurance of Sterility Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl Chemical Contamination: Products contain methanol and were below the label claim for ethanol content FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal Chemical Contamination: Products contain methanol and were below the label claim for ethanol content FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal Chemical Contamination: Products contain methanol and were below the label claim for ethanol content FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal Chemical Contamination: Products contain methanol and were below the label claim for ethanol content FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ Labeling: Label Mix-Up. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles Failed Dissolution Specifications Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medicine recall Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles Failed Dissolution Specifications Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereFlorida and Texas
- Medicine recall Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle Failed Dissolution Specifications Class IIIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. Class IIFDA’s classFeb 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Injection, USP 0.4 mg/2 mL Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials Class IIIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium for Injection 40mg/vial For I.V Failed Impurity/Degradation Specifications Class IIIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar Superpotent Drug. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous… Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For… Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd CGMP deviations. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution) Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. Class IIIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Injection 1,000 mg per 100 mL Discoloration and failed pH specifications Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Incorrect Labeling: Incorrect lot number on secondary packaging Class IIIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mephyton (phytonadione) Tablets 5mg, 100-count bottle Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. Class IIIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phytonadione Tablets 5mg, 30-count bottle Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D. Class IIIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Injection, USP, 30 mg per mL Presence of Particulate Matter - found in reserve sample vials at the firm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 3, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton Failed Dissolution Specifications Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz Labeling: Missing instructions for use insert Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for… CGMP deviations: Lack of potency testing. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for… CGMP deviations: Lack of potency testing. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for… CGMP deviations: Lack of potency testing. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for… CGMP deviations: Lack of potency testing. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. Class IIFDA’s classJan 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2021ClassClass 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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