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 Kushim Tablets (Gushim) 45-count packages, Label in foreign language Marketed Without an Approved NDA/ANDA. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Frovatriptan Succinate Tablets, 2.5mg Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date… Class IIIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho CF Cold & Flu with Honey, 6 FL Microbial Contamination of Non-Sterile Products Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho EX Expectorant, 6 FL Microbial Contamination of Non-Sterile Products Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall New! Rompe Pecho MAX Multi Symptoms, 8 FL Microbial Contamination of Non-Sterile Products Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets Failed Dissolution Specifications: Low out of specification results obtained during stability testing. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed… Presence of Foreign Tablets/Capsules: Complaint involving one Women’s Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer Presence of Foreign Tablets/Capsules: Complaint involving one Women’s Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Trom, 30 mg/1mL Inj Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 19, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 19, 2020ClassClass IStatusTerminatedWhereLouisiana and Oklahoma
- Medicine recall Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a… Class IIFDA’s classFeb 19, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 19, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ranitidine Hydrochloride (powder), USP CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report11 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, New Jersey, Pennsylvania, Rhode Island, South Carolina, Texas, Utah and Wyoming
- Medicine recall ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement Report12 statesnamed in where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Illinois, Indiana, Kentucky, Maine, Mississippi, Oklahoma, Oregon, Pennsylvania and Tennessee
- Medicine recall Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle Failed Dissolution Specifications: low out of specification results for dissolution testing. Class IIIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Olmesartan Medoxomil Tablets 20 mg cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine Hydrochloride Tablets, USP 0.1mg Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level… Class IIIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle GMP Deviations: Product bottle may be absent of desiccant. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle GMP Deviations: Product bottle may be absent of desiccant. Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing… Class IIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets. Class IIIFDA’s classFeb 12, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DHEA/Pregnenol One 10.25 MG Cap Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Finasteride/Biotin 1 mg/50 mcg Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Liothyronine (T3) 80 mcg SR cap Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Liothyronine (T3) 92.5 MCG Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Magic Bullet Supplement Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Naltrexone 4.5 mg capsule Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Progesterone 200 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Progesterone 50 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Progesterone E4M SR 100 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Sildenafil 200 mg Troche (Clinic) Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Sildenafil 80 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Squaric Acid 0.1% Topical Solution (Clinic) 30 mL Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall T3/T4 SR 9 mcg/38 mcg capsule Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Tadalafil 20 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Tadalafil 6 mg Capsule Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Testosterone Topical Cream 4% Labeling: Incorrect or missing lot and/or expiration date. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV Presence of Particulate Matter: Particulates observed in vials release for dispensing. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, District of Columbia, Florida, Indiana, Massachusetts, Montana, North Carolina, New Jersey, New York, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin
- Medicine recall Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10% Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing). Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product Class IIIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz Subpotent: Out of specification for assay at the 12-month time point. Class IIFDA’s classFeb 5, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nizatidine Capsules, USP 150 mg CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nizatidine Capsules, USP 300 mg CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count CGMP Deviations: Presence of NDMA impurity detected in product. Class IIFDA’s classJan 29, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 29, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, North Carolina and South Carolina
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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