Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Capecitabine 500 mg Tablet Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Bendeka 25 mg/mL 4 mL MDVPF Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Ondansetron 8 mg tablet Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Letrozole 2.5 mg tab Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Zarxio 300 mcg/0.5 mL PFS Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Tasigna Capsules 150 mg Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall OPDIVO 40 mg/4 mL SDV Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Kisqali 600 Dose 63 tablet 200 mg Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Lupron Depot 22.5 mg 3 month Kit Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human… Lack of Assurance of Sterility Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Michigan, South Carolina and Texas
- Medicine recall OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance… Class IIIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 16, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1) Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1) Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 16, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Linezolid Injection 600 mg per 300 mL Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Failed Dissolution Specification: Low dissolution outside of specifications Class IIIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Docetaxel injection concentrate, 20 mg/mL, 1 mL vial Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. Class IIFDA’s classMay 9, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 9, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles,… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50),… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18),… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles,… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles,… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the… Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee,… Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NEOstigmine Methylsulfate Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL Subpotent Drug Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL Subpotent Drug Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL Subpotent Drug Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles Failed Dissolution Specifications. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg, 100-count bottles Failed Dissolution Specifications. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles Failed Dissolution Specifications. Class IIIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CYANOCOBALAMIN Injectable-30 mL MDV Presence of Particulate matter. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ADENO-PLEX Injectable-30 mL MDV Presence of Particulate matter. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
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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