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 METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE… 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 MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ… 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 MIC-CARN MAX 15/100/50/1 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 MULTITRACE-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 NALBUPHINE HCL 20 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 NALTREXONE 1 MG/ML INJECTABLE and 200 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 NANDROLONE DECANOATE 100 MG/ML and 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 OXYTOCIN 10 UNITS/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 PARABEN WATER FOR 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 PHOSPHATIDYLCHOLINE 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 POTASSIUM CHLORIDE 2 MEQ/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 PROCAINE P/F 20 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 PROG/TEST CYP 15/7.5 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 PROGESTERONE 50 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 PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, 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 PYRIDOXINE HCL P/F 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 QUAD AMINO BLEND 150/75/150/75 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 SELENIUM 400 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 SERMORELIN ACETATE 10 MG 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 SODIUM BICARBONATE PF 8.4% 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 SODIUM HYDROXIDE 10% (W/V)/WATER FOR 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 CARBOplatin Injection, 600 mg/60ml, MultiDose Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer. Class IIFDA’s classSep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SexVoltz All Natural Herbal Supplement Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Velextra All-Natural Herbal Supplement Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 11, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 11, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg,… Class IIIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy,… Lack of Assurance of Sterility; product linked to adverse event reports of endophthalimitis eye infections and FDA inspection findings resulted in concerns… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Louisiana and South Carolina
- Medicine recall ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Magnesium Sulfate Injection, USP, 50% Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bethel 30 capsules Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL flexible container Presence of Particulate Matter; product may contain fibrous material FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Propranolol Hydrochloride Tablets, USP, 10 mg Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to… Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Inj., USP, 30 mg vial Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. Class IIFDA’s classSep 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2)… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count… Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909) Subpotent; Beta carotene (Vitamin A) Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mavik¿ trandolapril tablets 4mg, 100 count bottle Labeling: Incorrect Package Insert; product packaged with outdated version of the insert Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000… Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. Class IIIFDA’s classAug 28, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2013ClassClass IIIStatusTerminatedWhereNationwide
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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