Medicines, 2020
Shortlist up to four to read them side by side.
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 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot… Class IIFDA’s classApr 1, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereMissouri and Tennessee
- Medicine recall Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz SubPotent Drug: Low out-of-specification results for assay testing. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial Failed Stability Specifications Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display -… Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Class IIFDA’s classApr 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Tablets USP, 10mEq Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg. Class IIIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202 Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin’s Fenofibrate 145mg was observed… Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 25, 2020ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles Presence of particulate matter. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Capsules, USP, 75 mg, 100-count bottle CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Capsules, USP, 100 mg, 50-count bottle CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PrediniSONE Tablets, USP 5 mg, 48-count bottle Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg Class IIIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules… Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton,… Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel and shear. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel and shear. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel and shear. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel and shear. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, USP 40 mg Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Solifenacin Succinate Tablets, 5mg CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Solifenacin Succinate Tablets, 10 mg CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle CGMP Deviations: Presence of dark brown discoloration on edges of tablets Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride 0.9% Injection, USP, 1000 mL bags CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. Class IIFDA’s classMar 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sunstar GUM Toothpaste 3 g tubes, Toothpaste cGMP Deviation Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle Product Mix-Up: A foreign tablet was found in bottle. Class IIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate… Class IIIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate… Class IIIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate… Class IIIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate… Class IIIFDA’s classMar 18, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 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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