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 5, 2026.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For… Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating “Refrigerate Upon Arrival”, however product is labeled… Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials Subpotent Drug Class IIIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fulvestrant Injection 250mg/5mL Failed Impurities/Degradation Specifications Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen 325 mg tablets Failed Tablet/Capsule Specifications: Imprint “AP 325” is missing from the tablet. Class IIIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Acetaminophen 500 mg tablet, Extra Strength Failed Tablet/Capsule Specifications: Imprint “AP 325” is missing from the tablet. Class IIIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Ketorolac Tromethamine Injection, USP 60 mg/2 mL cGMP Deviations: deviations leading to potential cross-contamination. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite… CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2022ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois and New Jersey
- Medicine recall PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle Defective Container: Product has incomplete induction seals. Class IIFDA’s classAug 24, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister . Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic,… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant,… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Eye-stream, eye wash solution, sterile, 4 FL OZ CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dakin’s Solution, a) sodium hypochlorite 0.125%, quarter strength CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free,… CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alcohol Swabsticks, Antiseptic, 50 4” saturated individual packets per box CGMP Deviations: products were stored outside the drug label specifications. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles Lack of Assurance of Sterility: Complaints received of defective container closure. Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamotrigine Tablets, USP 100 mg, 1000-count bottles Labeling: Label Error on Declared Strength Class IIIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Prednisone Tablets USP, 20 mg, 100-count bottle Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FentaNYL Citrate Lack of Assurance of Sterility Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate Lack of Assurance of Sterility Class IIFDA’s classAug 17, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Azacitidine for Injection 100mg/vial Lyophilized Powder Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Class IIIFDA’s classAug 17, 2022in FDA’s Enforcement ReportOhiothe one state its words name PublishedAug 17, 2022ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall Naftifine Hydrochloride Gel, USP 1% Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Unspecified Impurity Relative Retention Time Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportKentuckythe one state its words name PublishedAug 10, 2022ClassClass IIStatusTerminatedWhereKentucky
- Medicine recall Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle Failed Dissolution Specifications: below specification limits for dissolution. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 10, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles Failed Dissolution Specifications: below specification limits for dissolution. Class IIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 10, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use Defective Container: Tube split from side seam Class IIIFDA’s classAug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 10, 2022ClassClass IStatusTerminatedWhereNationwide, and Florida named
- Medicine recall SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX… Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 10, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2022ClassClass 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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