Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, 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.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST9A Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST9A Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST9C Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix ST9E Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix SUPER Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-101 Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-102 Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-105 Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-106 Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle Failed Stability Specifications: product may not meet specification limit for assay test. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DuraPrep Surgical Solution Iodine Povacrylex Chemical contamination: Product may be contaminated with a toxic compound. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ImproVue Ophthalmic Lubricant Drops Falied pH specification Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT) Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops. Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Felodipine Extended-Release Tablets, 5 mg, 100 count bottles Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Felodipine Extended-Release Tablets, 10 mg, 100 count bottles Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Imipramine HCl Tablets, USP, 10 mg, 100 count bottles Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia,… Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia,… Chemical Contamination; benzophenone leached from the product label varnish Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles Presence of Foreign Substance: Presence of hair. Class IIIFDA’s classSep 16, 2015in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedSep 16, 2015ClassClass IIIStatusTerminatedWhereGeorgia
- Medicine recall Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ropivacaine HCl 0.2% Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereIdaho, Illinois, Pennsylvania and Virginia
- Medicine recall Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leucovorin Calcium capsules, 10 mg Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meloxicam capsules, 12 mg Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Artesunate Lyophilized Powder for Injection, 60 mg per vial Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methyl Folate Lyophilized Powder for Injection, 20 mg per vial Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle Failed Tablet/Capsule Specifications; report of oversized and discolored tablets Class IIIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28) Failed Dissolution Specifications Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol, Estriol, Progesterone capsules Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol, Estriol capsules Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estriol,Estradiol cream Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Est (estriol,estradiol) Testosterone cream Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol cream Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bi-Est (estriol,estradiol), Progesterone, Testosterone cream Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass 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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