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 Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Potassium Phosphate Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Praziquantel 56.8mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Progesterone 100 mg/ml in Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Progesterone EO 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Quadmix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Iodide 20% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Tetradecyl Sulfate Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Stanozolol (50 mg/ml and 100 mg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Testosterone Cypionate Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Trimix, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin A/D3/E Olive Oil Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin B12 (3000 mcg/ml & 5000 mcg/ml) Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin B12 Cyanocobalamin 5000 mcg Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Xylazine 300 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 17, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 17, 2013ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC… Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Heparin Sodium and 0.9% Sodium Chloride Injection, a) Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Chloride Injection, USP, a) Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015 Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing… Failed Dissolution Specifications: Pfizer Inc. Class IIIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing… Failed Dissolution Specifications: Pfizer Inc. Class IIIFDA’s classJul 10, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 10, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding Pharmacy, 318 Baston Road,… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Acetylcysteine 2 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA… Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Estradiol Valerate 20 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
- Medicine recall Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes Class IIFDA’s classJul 10, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 10, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia and South Carolina
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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