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 allergyrelief, 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 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 Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-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 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles Failed Moisture Limits: Water (moisture) content above the approved product specifications. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced… CGMP Deviation: impurities exceed allowable limits. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJul 19, 2023ClassClass IIStatusOngoingWhereTennessee
- Medicine recall 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container Lack of assurance of sterility: bags have the potential to leak. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate Injection, USP 8 mg per 20 mL Presence of Particulate Matter: Particulate matter identified as fiber. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bivalirudin for Injection 250 mg, 10 Single-Dose Vials Presence of Particulate Matter: Particulate matter identified as fiber. Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG Non-Sterility: FDA analysis found unopened products to have bacterial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same… Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Delsam Pharma’s ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG Non-Sterility: FDA analysis found unopened products to have bacterial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Delsam Pharma’s ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same… Class IIFDA’s classJul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 19, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 19, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Tizanidine Tablets, USP, 4 mg, 100 Tablets Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tizanidine Hydrochloride Tablet 4mg Failed Stability Specifications Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. Class IIFDA’s classJul 12, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 12, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Packaging defect: blister packaging inadequately sealed. Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Endometrin (progesterone) Vaginal Insert 100mg cGMP deviations: potential for Microbial Contamination of Non-Sterile Products Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kanjo Homeopathic Pain Relief Cream With Arnica cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arnica 7 Cream cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DoloEar Earache Drops, 0.50 fl cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SnoreStop Naso Spray Bulk, liquid cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall StellaLife VEGA Oral Care Rinse, 16 fl oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall StellaLife VEGA Oral Care Rinse, 16 fl oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall StellaLife VEGA Oral Care Spray, 1 fl oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall StellaLife VEGA Oral Care Gel, 1 fl oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall StellaLife VEGA Oral Care Gel, 1 fl oz cGMP deviations Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amphotericin B Liposome for Injection, 50mg/vial Subpotent drug Class IIFDA’s classJul 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 5, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 28, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 28, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L,… CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. Class IIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic… Chemical Contamination: FDA testing found Presence of methanol FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1… Chemical Contamination: FDA testing found Presence of methanol FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Tranexamic Acid USP Tablets, 650 mg, 30 tablets Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classJun 21, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Extended Phenytoin Sodium Capsules, USP, 100 mg Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) Class IIFDA’s classJun 21, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 21, 2023ClassClass IIStatusTerminatedWhereLouisiana, Ohio and Pennsylvania
- Medicine recall ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial Mislabeling: preservative free product labeled as preserved. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box… CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity… Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004% Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles CGMP Deviations Class IIFDA’s classJun 14, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 14, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL Labeling: Label Mix-up Class IIIFDA’s classJun 14, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 14, 2023ClassClass IIIStatusTerminatedWhereArizona, California and Texas
- Medicine recall Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
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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