Medicines, 2021
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1,016 medicine recalls FDA’s Enforcement Report published in 2021, 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.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe Failed Impurities/Degradation Specifications Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall Macula Pellets Homeopathic Medicine, 1 Oz bottles An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. Class IIIFDA’s classApr 14, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 14, 2021ClassClass IIIStatusTerminatedWhereColorado, Maryland and Texas
- Medicine recall Sp-4, 100 mL solution bottles An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. Class IIIFDA’s classApr 14, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 14, 2021ClassClass IIIStatusTerminatedWhereColorado, Maryland and Texas
- Medicine recall LCL-2-0191, 5 gallon carboys An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate. Class IIIFDA’s classApr 14, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 14, 2021ClassClass IIIStatusTerminatedWhereColorado, Maryland and Texas
- Medicine recall Guanfacine Extended-Release Tablets 2 mg,100-count bottles Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metformin HCl Extended-Release Tablets, USP, 500 mg Failed Moisture Limits: Out of specification for water content Class IIIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Telmisartan Tablets, USP 20 mg, 30-count bottles Labeling: Label-mixup FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC… CGMP Deviaitons Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neomycin Sulfate Tablets, USP 500mg Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay Class IIFDA’s classApr 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton Temperature Abuse Class IIIFDA’s classApr 7, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 7, 2021ClassClass IIIStatusTerminatedWhereAlabama, Louisiana, Mississippi and Tennessee
- Medicine recall Acyclovir Sodium Injection 1000mg/20mL Crystallization: customer complaints for crystallization in finished product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Sodium Injection 500mg/10mL Crystallization: customer complaints for crystallization in finished product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection… Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection… Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. Class IIFDA’s classApr 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adam’s Secret Extra Strength 1500, 800 mg, 10 count blister packs Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 31, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Adam’s Secret Extra Strength 3000, 840 mg, 10 count blister packs Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 31, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer Class IIFDA’s classMar 31, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 31, 2021ClassClass IIStatusTerminatedWherePennsylvania and Texas
- Medicine recall 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use Class IIFDA’s classMar 31, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 31, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nortriptyline HCL capsules, 10 mg cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently taken from an ingredient lot from an alternate supplier before… Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereGeorgia
- Medicine recall Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For… Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Spironolactone Tablets, USP, 25 mg Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolactone 50 mg tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Spironolactone Tablets, USP, 50 mg Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,… Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions Class IIIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe,… Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classMar 24, 2021in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 24, 2021ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. Class IIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Romidepsin Injecton, 27.5 mg/5.5 mL Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing. Class IIIFDA’s classMar 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 24, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Menopur 75 IU, (menotropins for injection) Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP Class IIIFDA’s classMar 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 17, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials Subpotent Class IIIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Famotidine Tablets USP 40mg, 1,000-count bottles Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Pennsylvania and Texas
- Medicine recall Atorvastatin Calcium Tablets, 40mg Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities Class IIIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Progesterone Capsules, 200 mg, 100-count bottles Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours Defective Delivery System: Out of specification for mechanical peel. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metoclopramide Injection USP, 10 mg/2 mL Chemical contamination; Unknown brown residue adhering to the inside of one vial. Class IIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylprednisolone Tablets USP, 4 MG Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card. Class IIIFDA’s classMar 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 10, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile… Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 3, 2021ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile… Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 3, 2021ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile… Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 3, 2021ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA),… Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 3, 2021ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 3, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01) Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility… Class IIFDA’s classMar 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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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