Medicines
Shortlist up to four to read them side by side.
704 medicine recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
704of 704 medicine recallsshown with your filters
The list
- Medicine recall Semaglutide, For Rx compounding use only CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nilotinib Capsules, 150 mg per capsule Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection… Class IIIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Nilotinib Capsules, 200 mg per capsule Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection… Class IIIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets Defective container; inadequately sealed blister packaging. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Product label: Temozolomide Capsules, 5mg Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles Stability Data Does Not Support Expiry Date. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles Stability Data Does Not Support Expiry Date. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles Stability Data Does Not Support Expiry Date. Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall SILINTAN 25/pills Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Sodium Iodide (I-131) Solution, Therapeutic Oral Presence of Particulate Matter: Due to production issues Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial Lack of Assurance of Sterility Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 11, 2026ClassClass IIStatusOngoingWhereOhio
- Medicine recall Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial Lack of Assurance of Sterility Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 11, 2026ClassClass IIStatusOngoingWhereOhio
- Medicine recall Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial Lack of Assurance of Sterility Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 11, 2026ClassClass IIStatusOngoingWhereOhio
- Medicine recall Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial Lack of Assurance of Sterility Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 11, 2026ClassClass IIStatusOngoingWhereOhio
- Medicine recall Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall MR. 7 SUPER 700000 capsules, 1 capsule blister card Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 11, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 11, 2026ClassClass IStatusOngoingWhereNo state named
- Medicine recall Amnesteem (Isotretinoin) Capsules, USP 40 mg Failed Dissolution Specifications Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For… Labeling: Not Elsewhere Classified. Class IIIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Agebox iKids-Growth (Day Formula) capsules, 60-count bottles Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Agebox iKids-Growth (Night Formula), 60-count bottles Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant… Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. Class IIFDA’s classMar 4, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 4, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle cGMP deviations Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle cGMP deviations Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle Tablets/Capsules Imprinted with Wrong ID Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211 Presence of Foreign substance - potential presence of metal particulate matter Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
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.
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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