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 EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Propofol Injectable Emulsion, 1%, 200 mg/20 mL Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance. Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN,… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all… Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance Class IIFDA’s classSep 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 18, 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.”
Your shortlist0 of 4
Add one more to compare.