Medicines, 2021
Shortlist up to four to read them side by side.
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 5, 2026.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Hand Sanitizer Foam (ethyl alcohol), 62% v/v Defective Container: Customer complaints for leaking bottles and dispensing issues. Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moxifloxacin, 1 mg/mL, 1mL Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle Failed Impurities/Degradation Specifications Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho DM, 6 Fl Oz Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho Ex Expectorant Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Penicillin V Potassium for Oral Solution, USP 125 mg Subpotent Class IIFDA’s classDec 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution, 1.5% w/w Defective container: Out of specification for container integrity leading to bottles leaking. Class IIFDA’s classDec 22, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 22, 2021ClassClass IIStatusOngoingWhereConnecticut, Florida and Kansas
- Medicine recall Lidocaine Hydrochloride Topical Solution USP 4% CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Hydrochloride Topical Solution USP 4% Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Hydrochloride Topical Solution USP 4% CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps… Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars Superpotent Drug Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 12mg/ml injection, 1 mL vials Lack of Processing Controls Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportMarylandthe one state its words name PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereMaryland
- Medicine recall B-Complex, injection, 1 mL vials Lack of Processing Controls Class IIFDA’s classDec 22, 2021in FDA’s Enforcement ReportMarylandthe one state its words name PublishedDec 22, 2021ClassClass IIStatusTerminatedWhereMaryland
- Medicine recall Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles Superpotent; Hydrochlorothiazide Class IIIFDA’s classDec 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 22, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IStatusCompletedWhereNationwide
- Medicine recall Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion,… Failed dissolution specifications Class IIIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle Product Mix-up Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 15, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag Crystallization: Product appears to be turbid. Class IIFDA’s classDec 15, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedDec 15, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only Lack of Assurance of Sterility Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only Lack of Assurance of Sterility Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only Lack of Assurance of Sterility Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and… Subpotent Drug Class IIIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit Lack of sterility assurance: bag has the potential to leak. Class IIFDA’s classDec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For… Temperature Abuse; temperature excursion during shipping FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 8, 2021ClassClass IStatusCompletedWhereNationwide
- Medicine recall Topiramate Tablets, USP 50 mg, 500-count bottles Discoloration Class IIIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Butalbital, APAP, Caf 50/325/40 Tablets Labeling: Not Elsewhere Classified: the controlled substance classification “CIII” is missing on the label Class IIIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Butalbital, APAP, Caf 50/325/40 Tablet Labeling: Not Elsewhere Classified: the controlled substance classification “CIII” is missing on the label Class IIIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz Defective Container Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz Defective Container Class IIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classDec 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 1, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg Labelling: Incorrect Exp. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton Failed Impurities/Degradation Specifications Class IIIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 24, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. Class IIFDA’s classNov 24, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 24, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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