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 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL and bupivacaine 0.125% PF Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 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: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 2 mcg/mL and bupivacaine 0.125% PF Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 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: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine 2%, 100 mg /5 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall midazolam in dextrose 5%, 50 mg /50 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall rocuronium, 50 mg /5 mL Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 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: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy… Lack of assurance of sterility: Lack of validation data for sanitization cycles Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and… Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use Lack of Assurance of Sterility Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use Lack of Assurance of Sterility Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use Lack of Assurance of Sterility Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methylphenidate Hydrochloride Tablets, USP 20mg Presence of Foreign Substance: Metal embedded in a tablet. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles Defective Delivery System Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant) CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine) CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For… Lack of Assurance of Sterility Class IIFDA’s classAug 2, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 2, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% cGMP deviations: due to shipment of rejected units. Class IIFDA’s classAug 2, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 2, 2023ClassClass IIStatusTerminatedWhereKentucky and New Jersey
- Medicine recall Tizanidine Tablets USP, 4 mg, 1000-Count bottle Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. Class IIIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fingolimod Capsules, 0.5 mg, 30-count bottle Failed Dissolution Specifications Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SUCCINYLcholine Chloride 200 mg/10mL CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume) CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Lack of Assurance of Sterility Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 4 mg per 250 mL Lack of Assurance of Sterility Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 8 mg per 250 mL Lack of Assurance of Sterility Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 16 mg per 250 mL Lack of Assurance of Sterility Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 32 mg per 250 mL Lack of Assurance of Sterility Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Famotidine Tablets, USP, 20mg, 200-count bottle within a carton Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating… Class IIFDA’s classJul 26, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 26, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles Failed Stability Specifications Class IIIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Original Eye Drops CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. Class IIIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 19, 2023ClassClass IIIStatusTerminatedWhereNationwide, and New Jersey and Tennessee named
- Medicine recall Allergy, Fexofenadine Hydrochloride Tablets, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets, 180 mg Failed Impurities/Degradation Specifications Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 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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