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 HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE… Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS Presence of foreign substance: small metallic particles in chewable tablets. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets Labeling: Not Elsewhere Classified. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets Labeling: Not Elsewhere Classified. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of… Class IIIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile Failed Stability Specifications Class IIIFDA’s classJun 3, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Primidone Tablets USP, 250mg, 100-count bottle Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Primidone Tablets, USP, 50 mg, 50-count bottle Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Primidone Tablets, USP, 250 mg, 100-count bottle Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Primidone Tablets, USP, 250 mg, 100 Tablets Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Primidone Tablets, USP, 50 mg, 100 Tablets Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 27, 2026ClassClass IIStatusOngoingWhereTexas
- Medicine recall Busulfan Injection, 60 mg per 10 mL Failed Impurities/Degradation Specifications Class IIIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Liraglutide Injection, 18 mg/3 mL Presence of particulate matter: a white thread-like structure in the cartridge Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton Defective Container; packets were found to be either empty or partially full. Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES Lack of Assurance of Sterility Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding… Subpotent Drug Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL,… Presence of a Foreign Substance; black particles observed in liquid Class IIFDA’s classMay 27, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedMay 27, 2026ClassClass IIStatusOngoingWhereOhio
- Medicine recall MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%) Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 27, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of… Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials Crystallization; identified as Buprenorphine free base Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Failed Dissolution Specifications Class IIFDA’s classMay 20, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle Subpotent drug Class IIIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal… Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal… Lack of Assurance of Sterility: Potential leaks from perforations in bags. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, 30 mg CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, 60 mg CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, 20 mg CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability… Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BD PurPrep, Povidone-iodine 8.3% w/w Lack of assurance of Sterility: potential product contamination Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BD PurPrep, Povidone-iodine 8.3% w/w Lack of assurance of Sterility: potential product contamination Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits… 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 60mg CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL Chemical contamination; presence of lead and lithium above specification Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag Incorrect Product Formulation: product did not contain insulin as listed in the label. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 13, 2026ClassClass IIStatusOngoingWhereCalifornia
- Medicine recall Lactated Ringer’s Injection USP, 1000 mL container Presence of Particulate Matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IStatusOngoingWhereNationwide
- Medicine recall Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GenTeal Tears, Lubricant Eye Gel, Sterile, 10g Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 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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