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 Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ Lack of Assurance of Sterility Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ Lack of Assurance of Sterility Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz Lack of Assurance of Sterility Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz Lack of Assurance of Sterility Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ Lack of Assurance of Sterility Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Magnesium Sulfate in Water for Injection, 4g/100 mL Product mix up: a foil pouch labeled “Magnesium Sulfate in Water for Injection, 4 g/100 mL” actually contained an IV bag of Tranexamic Acid instead. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic… Failed Tablet/Capsule Specifications Class IIIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial Lack of Assurance of Sterility Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle Subpotent Drug Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in… Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in… Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in… Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg… Failed tablet specifications. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Children’s Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pitavastatin Tablets, 2 mg Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg Class IIIFDA’s classMar 25, 2026in FDA’s Enforcement ReportTennesseethe one state its words name PublishedMar 25, 2026ClassClass IIIStatusOngoingWhereTennessee
- Medicine recall Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs… Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL Lack of Assurance of Sterility Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Webcol Alcohol Prep pad Non-Sterility: microbial contamination identified as Paenibacillus phoenicis FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 25, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000… 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 Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000… 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 Metoprolol Succinate Extended-Release Tablets 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 Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles 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 First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation,… CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall 1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5”x7” Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Medi-First Antiseptic Wipes (BZK)(Benzalkonium Chloride 0.13%), 100 wipes per box CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5” x7”, 1000 ea Bulk, Med-Nap, Brooksville, FL 34601 CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%) CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5” x 7” CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cleansing Towelette (Benzalkonium Chloride 0.13%), 5”x 7”, 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601 CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner… CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7 CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7 CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Children’s Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70% CGMP Deviations Class IIFDA’s classMar 11, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 11, 2026ClassClass IIStatusOngoingWhereNationwide
- 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
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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