Medicines, 2023
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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 5, 2026.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag Labeling: Not Elsewhere Classified Class IIIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% -… Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim. Class IIIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle Failed Dissolution Specifications Class IIIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Certain Over-The-Counter (OTC) drug products CGMP Deviations: OTC products were stored outside of labeled temperature requirements. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Sucralfate Oral Suspension, 1g per 10mL, 16 oz Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Doxil (doxorubicin hydrochloride liposome injection) 50 mg CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betaxolol Tablets, USP 10 mg Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 25, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL) Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefuroxime 4mg /0.4 mL Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe Lack of Assurance of Sterility Class IIFDA’s classOct 25, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 25, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 18, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 18, 2023ClassClass IStatusCompletedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road,… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine 2%, 100 mg/5 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall rocuronium, 50 mg/5 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture… Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL and bupivacaine 0.125% PF Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall midazolam in dextrose 5%, 50 mg/50 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 100 mcg/2 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 250 mcg/5 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 2500 mcg/50 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 2500 mcg/50 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL, 5,000 mcg/100 mL Lack of assurance of sterility: Class IIFDA’s classOct 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 11, 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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