Medicines, 2019
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2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Assorted Sidekick Floor Stand Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Redness Relief Club Pack Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Maximum Redness Relief Club Pack Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2… CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clear Eyes Redness Relief Hand Pocket Pal Tray Display CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bexarotene Capsules, 75 mg, 100 capsules per bottle Failed Dissolution Specifications Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereKentucky, Louisiana, New Jersey and Ohio
- Medicine recall Ketamine 50 mg/5 mL Lack of Assurance of Sterility. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle Failed dissolution specifications Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle Failed dissolution specifications Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall CVS Health Glycerin Suppositories, 50-count box CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion, 3.5 oz CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Therapeutic Menthol Gel, 8 FL OZ CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Children Glycerin Suppositories Laxative for ages 2 to 5 CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adult Glycerin Suppositories, Package Size 25-count suppositories CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adult Glycerin Suppositories, Package Size 50-count suppositories CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adult Glycerin Suppositories, Package Size 100-count suppositories CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Glycerin Suppositories, 100- count box CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cool Hot Ice Analgesic Gel, 8 oz CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kool Comfort Cooling Pain Relief, 5% Menthol CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5% CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CRYO-273 Cold Pain Relieving Gel 128 FL CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing… Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes Temperature Abuse: Complaints received of liquidy texture. Class IIIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Abraxane 170 MG / 34 ML IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Adcetris 96 MG/100 ML NS IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall ADO-TRASTUZUMAB 210 MG/250 ml NS Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall AVASTIN 630 MG / 100 ML 0.9% NACL IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall BEVACIZUMAB 784 MG / 100 ML NS IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall BLEOMYCIN 18 UNITS / 100 ML NS IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall CARBOPLATIN 174 MG / 250ml NS IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall CARFILZOMIB 65 MG Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
- Medicine recall CETUXIMAB 335 MG / 167.5 ML IVPB Lack of Assurance of Sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNew York
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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