Medicines, 2024
Shortlist up to four to read them side by side.
657 medicine recalls FDA’s Enforcement Report published in 2024, 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.
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The list
- Medicine recall Gelato, Benzocaine 20% Topical Gel Anesthetic Gel CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20% CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Health-Tec, Topical Anesthetic Gel, Benzocaine 20% CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of… Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nebivolol Tablets, 2.5 CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules Discoloration Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators CGMP deviations: out of specifications for assay Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles Lack of Sterility Assurance Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles Lack of Sterility Assurance Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine Tablets, USP 2.5 mg, 30-count bottle Failed Impurities/Degradation Specifications Class IIFDA’s classDec 25, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2… Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free… Class IIIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNew Jersey
- Medicine recall Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack CGMP Deviations: Released product should have been rejected. Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials cGMP Deviations: Temperature excursion Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 18, 2024ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets USP, 125 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 137 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 150 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 175 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 200 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 25 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 50 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 75 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 88 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 100 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levothyroxine Sodium Tablets USP, 112 mcg Superpotent Drug and Subpotent Drug: potency failures obtained Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Dabigatran Etexilate, 75 mg capsules, 60-count bottles CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dabigatran Etexilate, 150mg capsules, 60-count bottles CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 100 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 112 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 125 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 137 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 150 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 175 mcg Subpotent and Superpotent Drug Class IIFDA’s classDec 18, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 18, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 75 mcg Subpotent drug Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cinacalcet Tablets, 30 mg cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 60mg cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cinacalcet Tablets, 90 mg cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL Presence of Particulate Matter: Potential for glass delamination from the vials. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL Presence of Particulate Matter: Potential for glass delamination from the vials. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass 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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