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 5, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lamotrigine Tablets, USP, 200 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, USP, 5 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ciprofloxacin Tablets, USP, 500 mg,100-count bottles CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, USP 10 mg CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Irinotecan Hydrochloride Injection, 40 mg/2 mL Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irinotecan Hydrochloride Injection, 100 mg/5 mL Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ropinirole, extended-release tablets, 2 mg, 90 count bottle Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of… Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Propofol Injectable Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. Class IIFDA’s classNov 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab 25mg/mL, prepared as pre-filled syringes Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party… Class IIFDA’s classNov 6, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 6, 2013ClassClass IIStatusTerminatedWhereMaine and New York
- Medicine recall GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl Subpotent; phenylephrine HCl Class IIIFDA’s classOct 30, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedOct 30, 2013ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Ketoconazole Shampoo, 2% Subpotent Class IIIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalation Only Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in… Class IIFDA’s classOct 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Concentrated Motrin (ibuprofen) Infants’ Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50… Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed Class IIFDA’s classOct 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial Lack of Assurance of Sterility; potential for vial breakage Class IIFDA’s classOct 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Next Choice” One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC… Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. Class IIFDA’s classOct 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydroxychloroquine Sulfate Tablets, USP, 200 mg Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some… Class IIIFDA’s classOct 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen Tablets, 500 mg, 100-count bottles CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the… Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ifosfamide Injection 1g/20mL, Single dose vial Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ifosfamide Injection 3g/60 mL, Single dose vial Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg Failed Dissolution Specification:12 hour time point at 18 months of product shelf life. Class IIIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Histamine, 10 ng/mL Injectable, MDV Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls Presence of Particulate Matter; report of visible particulates in the glass ampule Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st… Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy’s independent testing laboratory. Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy’s independent testing laboratory Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets,… Class IIFDA’s classOct 9, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 9, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyridostigmine Bromide Tablets 60 mg, USP Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing. Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as… Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of… Class IIFDA’s classOct 2, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 2, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyaluron (hyaluronidase) 150 units/mL Preserved Solution, 1 mL, Multi Dose Vial, Compounded by Leiter’s… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter’s Compounding Pharmacy, 1700… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter’s Compounding… Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered… Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Sodium Thiosulfate 25%, 250 mg/mL Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB… Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Epinephrine 1:1,000 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. Class IIFDA’s classSep 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 25, 2013ClassClass 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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