Medicines, 2023
Shortlist up to four to read them side by side.
1,252 medicine recalls FDA’s Enforcement Report published in 2023, 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.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton,… Presence of Particulate Matter: Silicone FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL Presence of Particulate Matter: Silicone FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride… Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%) Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 22, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medicine recall DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 22, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medicine recall Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not… Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 22, 2023ClassClass IIStatusOngoingWherePuerto Rico
- Medicine recall Oxygen, Compressed USP, UN 1072 cGMP Deviations Class IIFDA’s classNov 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Montelukast Sodium Tablets, USP 10 mg Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use Crystallization; identified as Buprenorphine free base Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Synthroid, Levothyroxine Sodium Tablets, USP 125mcg Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as… Class IIIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 15, 2023ClassClass IIIStatusOngoingWhereNo state named
- Medicine recall Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of… Class IIIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle Failed Dissolution Specifications Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low… Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle Failed Dissolution Specifications: Out of specification for dissolution. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water. Class IIIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle Sub-potent Drug: Lower potency than labeled. Class IIIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle Failed Dissolution Specifications Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point. Class IIFDA’s classNov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 15, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall V-FORCE Homeopathic, 1 FL OZ Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the… Class IIIFDA’s classNov 15, 2023in FDA’s Enforcement ReportFloridathe one state its words name PublishedNov 15, 2023ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL Presence of Particulate Matter: identified as glass. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 15, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe Presence of Particulate Matter: identified as glass. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 15, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe Presence of Particulate Matter: identified as glass. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 15, 2023ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine Subpotent Drug Class IIIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2% Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the… Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Strong Iodine Solution U.S.P. (Lugol’s Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles Failed Impurities/Degradation Specifications. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles Failed Impurities/Degradation Specifications. Class IIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classNov 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 8, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and… Class IIIFDA’s classNov 1, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 1, 2023ClassClass IIIStatusOngoingWhereMississippi and Ohio
- Medicine recall ION*Sinus Spray, 1 fl oz/ 30 mL Microbial contamination of Non-Sterile Products FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IStatusTerminatedWhereNationwide
- Medicine recall ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles Microbial contamination of Non-Sterile Products Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Restore Sinus Spray Microbial contamination of Non-Sterile Products Class IIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag Labeling: Not Elsewhere Classified Class IIIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag Labeling: Not Elsewhere Classified Class IIIFDA’s classNov 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 1, 2023ClassClass IIIStatusTerminatedWhereNationwide
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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