Medicines, 2023
Shortlist up to four to read them side by side.
1,252 medicine recalls FDA’s Enforcement Report published in 2023, 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.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MSA 7.84% MSG 8.56% Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Acetate Injection, 2 mEq/mL, 500 ml bag Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine 2% HCl Inj, 500mL bag Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HyperLyte CR Injection, 500 mL bag Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HyperLyte CR Injection, 250 mL bag Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft… Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging… Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glimepiride Tablets, USP, 1 mg, RX CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glimepiride Tablets, USP, 2 mg, RX CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glimepiride Tablets, USP, 4 mg, RX CGMP Deviations: recalling drug products following an FDA inspection. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC… CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets Failed Dissolution Specifications; during stability testing Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nafcillin for Injection, USP, 1 gram per vial Lack of Assurance of Sterility Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nafcillin for Injection, USP, 2 gram per vial Lack of Assurance of Sterility Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package Lack of Assurance of Sterility Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles Failed Impurities/Degradation Specifications: firm’s investigation due to customer complaints for discoloration found that the product was out of specification… Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Fentanyl Buccal Tablets CII, 100mcg Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Buccal Tablets CII, 200mcg Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Buccal Tablets CII, 400mcg Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Buccal Tablets CII, 600mcg Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Buccal Tablets CII, 800mcg Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial Sub-potent Drug Class IIFDA’s classMay 31, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 31, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01) Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial Lack of Assurance of Sterility: Malformed crimped collar seal Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LORazepam Injection, 2mg / mL Single Dose vial 1ml vial CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 24, 2023ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045,… CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medicine recall Pyrazinamide, 500 mg Tablet CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity… Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMay 24, 2023ClassClass IIStatusOngoingWherePennsylvania
- Medicine recall Heparin Sodium, 25,000 USP units per 250mL Subpotent: Low anti-factor IIa Potency. Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 250 mg per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 500 mg per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 1g per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 2g per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP, 250 mg per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 500 mg per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 1g per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 2 g per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 3 gram per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 3 grams per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 3 grams per vial Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package Lack of Assurance of Sterility Class IIFDA’s classMay 24, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 24, 2023ClassClass 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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