Medicines, 2022
Shortlist up to four to read them side by side.
1,349 medicine recalls FDA’s Enforcement Report published in 2022, 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.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup Microbial Contamination of Non-Sterile Products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup Microbial Contamination of Non-Sterile Products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension,… Microbial Contamination of Non-Sterile Products. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension,… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CORRECTDOSE Children’s ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CORRECTDOSE Children’s PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CORRECTDOSE Children’s COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL)… CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise… Class IIFDA’s classSep 14, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl cGMP deviation: Product held outside of appropriate temperature storage conditions. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Georgia, Idaho, Indiana, Montana, New Mexico, Nevada, Oregon, Texas and Utah named
- Medicine recall Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point. Class IIIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate. Class IIIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate… Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Luxury 70% Isopropyl Alcohol, 16 FL Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportVirginiathe one state its words name PublishedSep 7, 2022ClassClass IIStatusOngoingWhereVirginia
- Medicine recall Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportVirginiathe one state its words name PublishedSep 7, 2022ClassClass IIStatusOngoingWhereVirginia
- Medicine recall Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Class IIFDA’s classSep 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Extended Release Tablets, USP, 250 mg Failed dissolution specifications. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Novelty Hand Sanitizer with Silicone Wrap CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall AMBI Skin Cream for normal skin 2 OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dermasil Dry Skin Treatment 10 OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall COLGATE MAX FRESH CLEAN MINT 1.9OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Listerine Cool mint Mouthwash 250 mL CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hydrogen Peroxide 16 fl CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ready in case ACETAMINOPHEN PM CAPLETS 24 CT CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MOTRIN IB CAPLETS 24CT SKU999394 CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ CGMP Deviations: product held outside appropriate storage temperature conditions. Class IIFDA’s classAug 31, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2022ClassClass 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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