Medicines, 2013
Shortlist up to four to read them side by side.
1,376 medicine recalls FDA’s Enforcement Report published in 2013, 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 6, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall TG 40PSE/400GFN Tablets, 1000 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Trigofen Drops, Antihistamine, Decongestant,1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Metronidazole Tablets, USP, 500 mg Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Tri-Mix Injections Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Maine and Minnesota
- Medicine recall Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, Novartis Consumer Health, Inc.,… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Target Up & Up, athlete’s foot cream, full prescription strength, terbinafine hydrochloride 1% antifungal, 30… Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifungal), a) 12 g (.42 oz) Tube Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) Tubes and 30 gm Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Disulfiram Tablets USP 250 mg, 100 tablet bottle CGMP Deviation; cotton coil is missing in some packaged bottles Class IIIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 12, 2013ClassClass 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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