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 Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b)… Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by… Lack of Assurance of Sterility; reports of adverse events after injection Class IIFDA’s classMay 22, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereFlorida, Missouri, Utah and Washington
- Medicine recall BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride… Subpotent; Cetylpyridinum Chloride Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 22, 2013ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Furosemide Injection, USP, 40 mg/4mL Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall QUELICIN (succinylcholine chloride) Injection, USP, 200 mg Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Acetate Injection, USP, 40 mEq/20 ml Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Plavix 75 mg, 30 count bottle Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA). Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereNorth Carolina
- Medicine recall Liothyronine Sodium Tablets, USP, 5 mcg Failed Impurities/Degradation Specifications: 3 month stability testing. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Percocet 10/325 mg tablets, 100-count tablets per bottle Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form. Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall Acetic Acid Otic Solution, USP, 15 mL bottle Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station. Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#:… Chemical contamination: Firm’s inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the… Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Jevantique (norethindrone acetate and ethinyl estradiol) tablets Chemical contamination: Firm’s inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the… Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( Chemical contamination: Firm’s inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the… Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10) Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine. Class IIIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall “Well at Wallgreens” Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas) Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the… Class IIFDA’s classMay 8, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall WOW, Health Enterprises, Dietary Supplement, 30 Caplets Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 1, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amoxicillin Capsules USP 500 mg Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets, USP 10 mg Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets.. Class IIIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TriMix Standartd (PGE Stock Sol’n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall BiMix Plus Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc.,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall Quadmix Custom Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall 17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall QuadMix Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc.,… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
- Medicine recall DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division… Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereColorado, Georgia, Michigan and Puerto Rico
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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