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 5, 2026.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Busulfan Injection 60 mg/10 mL CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Imatinib Mesylate Tablets 100 mg CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Imatinib Mesylate Tablets 400 mg CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Docetaxel Injection USP 160 mg/8mL CGMP Deviations Class IIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor) Labeling: Label mix-up Class IIIFDA’s classDec 16, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 16, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 9, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 9, 2020ClassClass IStatusTerminatedWhereFlorida and New York
- Medicine recall ARIPIPRAZOLE TABLETS, 15 mg, 30-count FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health Hydrating Healing Ointment (Petrolatum 41%) Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportRhode Islandthe one state its words name PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereRhode Island
- Medicine recall Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton Failed Dissolution Specifications: Out of specification for dissolution. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing. Class IIIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel Microbial Contamination of Non-Sterile Drug Product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Ointment USP 0.05% Superpotent and Subpotent; low and high assay results Class IIIFDA’s classDec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 9, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Anagrelide Capsules, USP 1 mg, 100 capsules Failed Dissolution Specifications FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 9, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 9, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tizanidine Tablets, USP 4mg Failed Dissolution Specifications; Out of Specification (low) results were obtained. Class IIFDA’s classDec 9, 2020in FDA’s Enforcement ReportMichiganthe one state its words name PublishedDec 9, 2020ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70% CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 2, 2020ClassClass IIStatusCompletedWhereTexas
- Medicine recall Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IStatusCompletedWhereNationwide
- Medicine recall clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle Failed Tablet/Capsule Specification Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL Cross Contamination with Other Products: trace amounts of octreotide found during testing Class IIIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 2, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL… Marketed without an Approved NDA/ANDA: Product marketed with drug claims. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Felodipine Extended Release Tablets, USP 10 mg,100-count bottle Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity… Class IIIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Tablets, USP 500 mg Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets. Class IIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. Class IIIFDA’s classDec 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 2, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcohol 70%), 8 fl oz. 237 mL bottle CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol 70% v/v) 8 fl oz CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 fl oz/ 237 mL bottle CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL B Prox10 Anti-Blemish Wash (Benzoyl Peroxide 10%), 200 ml/6.7 fl.oz GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall (Malin + Goetz) Salicylic Gel GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%,… GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall MD Complete Breakout Treatment (Benzoyl Peroxide 4.5%) 1 fl GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL Alpha Beta Gel Toner GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DCL Clear Skin Anti-Blemish Hydrator GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics GMP Deviations Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325mg 100-count bottles Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium Tablets, USP… Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Homeopathic Energy Catalyst, 1 fl oz Labeling: Product Contains Undeclared API; Incorrect formulation Class IIIFDA’s classNov 25, 2020in FDA’s Enforcement ReportUtahthe one state its words name PublishedNov 25, 2020ClassClass IIIStatusTerminatedWhereUtah
- Medicine recall Testosterone Gel 1%, 2.5 grams per unit dose Superpotent Drug: High out-of-specification assay results were obtained during stability testing. Class IIIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a… Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial. Class IIFDA’s classNov 25, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 25, 2020ClassClass IIStatusTerminatedWhereNationwide
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.
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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