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 Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of… 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 Diacetate 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 Triamcinolone Acetonide 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 HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of… Lack of Sterility Assurance 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 for 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 BiMix 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 Cyclosporin in Corn Oil 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 Propofol Injectable Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level. Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per… Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they… Class IIFDA’s classMay 1, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point. Class IIIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Copaxone (glatiramer acetate injection), 20 mg/1 mL Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Children’s Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59) Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product’s name includes the word “Children’s” which is misleading… Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 25 mcg Chemical contamination: emission of strong odor after package was opened.. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 50 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 75 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 88 mcg Chemical contamination: emission of strong odor after package was opened.. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 100 mcg Chemical contamination: emission of strong odor after package was opened.. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 112 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 125 mcg Chemical contamination: emission of strong odor after package was opened Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 137 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 150 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 175 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Levoxyl (levothyroxine sodium) tablets, USP 200 mcg Chemical contamination: emission of strong odor after package was opened. Class IIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 24, 2013ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL flexible container Non-Sterility: Confirmed customer complaint of product contaminated with mold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL flexible containers Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted) Discoloration; Product may not meet specifications for color description once reconstituted. Class IIIFDA’s classApr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2013in FDA’s Enforcement ReportUtahthe one state its words name PublishedApr 24, 2013ClassClass IStatusOngoingWhereUtah
- Medicine recall LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC… Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets by the manufacturer Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21… Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle… Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. Class IIIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cefdinir for Oral Suspension, 125 mg/5 mL Defective Container: This recall is being carried out due to the potential for improperly sealed bottles. Class IIFDA’s classApr 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 17, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90… Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 mg Aniracetam Capsules 60 count bottle, OTC Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 count bottle, OTC,… Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC, BoostYourGrade, LLC, Orlando,… Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall BoostYourGrade.com, Piracetam 390mg Choline 104mg capsules, 250 count bottle, OYC, BoostYourGrade, LLC,… Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90… Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class IIFDA’s classApr 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida and Idaho
- Medicine recall CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80) Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time… Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fougera Ketoconazole Cream 2%, 15g tube Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result… Class IIIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 50 mL Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. Class IIFDA’s classApr 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 10, 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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