Medicines, 2012
Shortlist up to four to read them side by side.
434 medicine recalls FDA’s Enforcement Report published in 2012, 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.
434of 434 medicine recallsshown with your filters
The list
- Medicine recall CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL Lack of Assurance of Sterility; the firm’s medical trays contain Hospira’s 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereGeorgia, Massachusetts and Maryland
- Medicine recall CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL Lack of Assurance of Sterility; the firm’s medical trays contain Hospira’s 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereGeorgia, Massachusetts and Maryland
- Medicine recall Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation Misbranded Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the… Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Morton, Sodium Chloride, USP, Granular Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP… Class IIIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mercaptopurine Tablets, USP, 50 mg Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution. Class IIFDA’s classAug 29, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ACYCLOVIR OPHTHALMIC 3% OINTMENT 5 GM Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AFLIBERCEPT, SDPF Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALTEPLASE, SDPF Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML;… Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AMINOPHYLLINE 20ML, SDV** 500MG Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AMPHOTERICIN B OPHTHALMIC Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BACLOFEN, P.F. (WITH 0.9% P.F Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30… Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BEVACIZUMAB & DXM, SDPF Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BIEST(80/20) 6.25MG/GM Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BORON 2MG/ML INJECTABLE 40 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML,… Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML Lack of Assurance of Sterility: Franck’s Lab Inc. Class IIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIStatusTerminatedWhereNationwide
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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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