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 Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium USP, 50 mg CGMP deviation: Product found to contain trace amounts of NMBA Class IIFDA’s classMay 5, 2021in FDA’s Enforcement Report14 statesnamed in where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Ohio, Oregon, Wisconsin and Wyoming
- Medicine recall Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100 Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNo state 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 because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IStatusTerminatedWhereNationwide
- 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 because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IStatusTerminatedWhereNationwide
- 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 because at labeled storage conditions of 30*C/75% Relative Humidity, growth of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IStatusTerminatedWhereNationwide
- 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 Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile… Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA),… Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile… CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile… CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of… Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PremierZen Platinum 5000 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Triple SupremeZen Gold 3500 Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil. Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Oxygen, Compressed, USP UN 1072 cGMP deviations Class IIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Evrysdi (risdiplam) for oral solution, 60 mg/80mL Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so… Class IIIFDA’s classMay 5, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 5, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Transdermal System Delivers 0.0375 mg/day, 8 Systems/box Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flurandrenolide Ointment USP, 0.05% Failed Impurities/Degradation Specifications: Class IIFDA’s classApr 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 28, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card. Class IIIFDA’s classApr 21, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 21, 2021ClassClass IIIStatusOngoingWhereAlabama, California and Louisiana
- Medicine recall Lidocaine Ointment USP, 5% Failed Stability Specifications: product did not meet viscosity results. Class IIIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cefprozil for Oral Suspension USP, 250mg/5mL Superpotent Drug Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Itraconazole Capsules, 100 mg, 30-count bottles Failed Dissolution Specifications Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl Microbial Contamination of Non-Sterile Product Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lite’n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam… Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam… CGMP Deviations Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container,… CGMP Deviations Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lite’n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 1 US Gallon/ 3.79 Liters… CGMP Deviations Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lite’n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Contents: 18 oz/ 532 ml… CGMP Deviations Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lite’n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Contents: 18 oz/ 532 ml per foam pump… CGMP Deviations Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package,… Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall OZEMPIC (semaglutide) injection, 2 mg/1.5 mL Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Saxenda (liraglutide) Injection, 18 mg/3 mL Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ViCTOZA (liraglutide) injection, 18 mg/3 mL Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… Class IIFDA’s classApr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled… Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 21, 2021ClassClass IStatusTerminatedWhereNationwide
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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