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 Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial Presence of Particulate Matter: glass delamination Class IIFDA’s classDec 26, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereCalifornia and Pennsylvania
- Medicine recall Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125… Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. Class IIIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive,… Presence of Particulate Matter; potential for charcoal particulates Class IIIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CellCept (mycophenolate mofetil) capsules, 250 mg Short Fill: some bottles contained less than 120-count per labeled claim. Class IIIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clean & Clear advantage, 3-in-1 foaming wash 8 FL Superpotent (Single Ingredient Drug): salicylic acid Class IIIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl Injection, USP, 1% Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle Subpotent (Single ingredient) drug : This is a sub recall of Teva’s Enjuvia due to low Out of Specification (OOS) assay results. Class IIIFDA’s classDec 19, 2012in FDA’s Enforcement ReportVirginiathe one state its words name PublishedDec 19, 2012ClassClass IIIStatusTerminatedWhereVirginia
- Medicine recall Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle Subpotent (Single ingredient) drug : This is a sub recall of Teva’s Enjuvia due to low Out of Specification (OOS) assay results. Class IIIFDA’s classDec 19, 2012in FDA’s Enforcement ReportVirginiathe one state its words name PublishedDec 19, 2012ClassClass IIIStatusTerminatedWhereVirginia
- Medicine recall Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle Subpotent (Single ingredient) drug : This is a sub recall of Teva’s Enjuvia due to low Out of Specification (OOS) assay results. Class IIIFDA’s classDec 19, 2012in FDA’s Enforcement ReportVirginiathe one state its words name PublishedDec 19, 2012ClassClass IIIStatusTerminatedWhereVirginia
- Medicine recall Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with… Class IIIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Thyro-Tab 0.050 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.088 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.112 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.125 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.137 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Thyro-Tab 0.300 mg. cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles cGMP Deviations; does not meet in process specification requirements Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluorouracil Topical Cream USP, 5%, 40 g Tube Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080 Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080 Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol… Class IIFDA’s classDec 12, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) Marketed without an approved NDA/ANDA: Samantha Lynn Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered… Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. Class IIIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification. Class IIIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Arranon (nelarabine) Injection 5mg/mL, 50mL Vials Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets per bottle Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates. Class IIFDA’s classDec 5, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IStatusOngoingWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddy’s Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy’s Laboratories… Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Limed Bone Gelatin Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex) Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as “ointment” instead of “solution.” Class IIIFDA’s classNov 21, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 21, 2012ClassClass IIIStatusTerminatedWhereFlorida, Pennsylvania and Virginia
- Medicine recall Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor Labeling: Label Mix-up: Product was incorrectly labeled,”Tabs” instead of “Capsules.” Class IIIFDA’s classNov 21, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 21, 2012ClassClass IIIStatusTerminatedWhereGeorgia and Tennessee
- Medicine recall All Sterile Products Lack of Assurance of Sterility Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All Non Sterile Products GMP Deviations Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All Sterile Products Lack of assurance of sterility Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass 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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