Medicines, 2022
Shortlist up to four to read them side by side.
1,349 medicine recalls FDA’s Enforcement Report published in 2022, 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.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall LL-37 2 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Melanotan II 1 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PT-141 (Bremelanotide Acetate) 10 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin Acetate 1 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz Chemical Contamination: presence of benzene, acetaldehyde, and acetal. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall artnaturals Hand Sanitizer CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot Class IIFDA’s classApr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall IDArubicin Hydrochloride Injection USP 5gm/5mL Presence of Particulate Matter: Product was found to contain silica and iron oxide FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial Subpotent Drug: Out of Specification results for Assay Class IIIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereIllinois
- Medicine recall Preferred Pharmaceuticals, Inc Out of specification results observed in dissolution during long term stability testing. Class IIFDA’s classApr 20, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study… Class IIFDA’s classApr 20, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 20, 2022ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENOBARBITAL Sodium Injection, USP, 65mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENOBARBITAL Sodium Injection, USP, 130 mg/mL Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 23.4% Sodium Chloride Injection, 120 mEq per 30 mL Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride… Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle Presence of foreign substance: Presence of stainless steel particulates in tablets. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction… Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies. Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for… Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sucralfate Oral Suspension, USP 1g/10mL Labeling: Label Mix-Up Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall The Natural Dentist Healthy Breath Antiseptic Rinse, Cool Mint, 16.9 FL OZ Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Peppermint Oil and Sage Oil and has the wrong UPC Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylprednisolone Tablets, USP 4mg, 100-count bottle Subpotent Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Orphenadrine Citrate Extended-Release Tablets, USP 100 mg CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12.5 mg*, 90 Tablets bottles CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12.5 mg 90 tablets bottle CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12.5 mg, 90 tablets bottles CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit. Class IIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Risedronate Sodium Tablets, USP, 5 mg FAILED CONTENT UNIFORMITY SPECIFICATIONS Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SYMJEPI (epinephrine injection, USP) 0.3 mg Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SYMJEPI (epinephrine injection, USP) 0.15 mg Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Cequa (cyclosporine ophthalmic solution) 0.09% Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. Class IIIFDA’s classApr 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 13, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Class IIIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 6, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample Class IIIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedApr 6, 2022ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall (CA) GONADORELIN Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TESTOSTERONE CYPIONATE *GS* Lack of sterility assurance. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room. Class IIFDA’s classApr 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
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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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