Medicines, 2020
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1,035 medicine recalls FDA’s Enforcement Report published in 2020, 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.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Dexmedetomidine HCl Cross Contamination with other products: trace amounts of lidocaine FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL Discoloration and Presence of Foreign Substance Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%,… Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportColoradothe one state its words name PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereColorado
- Medicine recall Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found… Class IIIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BusPIRone Hydrochloride Tablets, USP 7.5 mg Failed Impurity /Degradation Specifications Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets CGMP Deviations Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets CGMP Deviations Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP, 50 mg, 90 count bottles Failed Tablet/Capsule Specification; complaint of bulging tablet Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol cGMP deviations Class IIFDA’s classSep 2, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2020ClassClass IIStatusCompletedWhereAlabama and Georgia
- Medicine recall HAND SANITIZER Non-sterile Solution 70% Topical Solution cGMP deviations Class IIFDA’s classSep 2, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2020ClassClass IIStatusCompletedWhereAlabama and Georgia
- Medicine recall Heparin Sodium 2,500 units Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 5,000 units Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 5,000 units Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 10,000 units Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Elitek (rasburicase) for injection, 7.5 mg vial Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prednisone Tablets, USP 2.5 mg, 100 tablets Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BD ChloraPrep Clear 3 mL Applicators Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereGuam and Puerto Rico
- Medicine recall ChloraPrep With Tint Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereGuam and Puerto Rico
- Medicine recall ChlroraPrep One-Step Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 26, 2020ClassClass IStatusTerminatedWhereGuam and Puerto Rico
- Medicine recall Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per… Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. Class IIIFDA’s classAug 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 26, 2020ClassClass IIIStatusTerminatedWhereIllinois and Texas
- Medicine recall Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed. Class IIIFDA’s classAug 26, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 26, 2020ClassClass IIIStatusTerminatedWhereIllinois and Texas
- Medicine recall Hydrochlorothiazide 25mg tablets CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrochlorothiazide (HCTZ) Orange Tabs 25mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrochlorothiazide 50mg tablets, 14-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid 1 Grain Tablets, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid 1 Gr tablets, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid Neutral Tabs 2 gr, 28-count tablets CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Topiramate 25mg Tabs White/round tablets, 10-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phendimetrazine Yellow Tabs 35mg, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phendimetrazine Yellow Tabs 35mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine 15mg grey/Yellow Capsules, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL GrayYellow capsules, 15mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL Yellow Caps 30mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL Blue/Clear capsules, 30mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL White/Blue Speckled tablets, 37.5 mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentermine HCL Blue Speckled tablets, 37.5 mg CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leucovorin Calcium Tablets USP, 10 mg Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. Class IIIFDA’s classAug 19, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 19, 2020ClassClass IIIStatusTerminatedWhereMississippi and Ohio
- Medicine recall Lidocaine Patch 5% Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl Subpotent drug: Out of specification for assay at the 15-month test interval. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 5,000 units Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class IIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity. Class IIIFDA’s classAug 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 19, 2020ClassClass IIIStatusTerminatedWhereNationwide
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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