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 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of… Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of… Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion… Class IIIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point. Class IIIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex. Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups Impurities/Degradation Products: exceeded specification at 3 month stability testing Class IIFDA’s classJul 18, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 18, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules USP, 5mg, 100 count bottle Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules USP, 10mg, 100 count bottle Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules USP, 25mg, 100 count bottle Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules USP, 50mg, 100 count bottle Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons,… Defective Container; damaged blister units Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per… Class IIIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed… Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed… Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight) Class IIFDA’s classJul 11, 2012in FDA’s Enforcement ReportOhiothe one state its words name PublishedJul 11, 2012ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life Class IIFDA’s classJul 4, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereGeorgia and Pennsylvania
- Medicine recall Thyro-Tab 0.050mg. Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 50 mcg. Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyro-Tab.075 mg. Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate… Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications. Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 4, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nisoldipine Extended Release Tablets, 17mg, 100 count bottle Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point Class IIFDA’s classJul 4, 2012in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 4, 2012ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall LifeGas OXYGEN COMPRESSED UN1072 USP CGMP Deviations: The pressure gages, vacuum gages, and thermometer had surpassed the calibration expiry period, which may have resulted in overfill/underfill… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereOhio
- Medicine recall Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets,… Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 27, 2012in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 27, 2012ClassClass IStatusTerminatedWhereFlorida
- Medicine recall Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 27, 2012in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 27, 2012ClassClass IStatusTerminatedWhereFlorida
- Medicine recall Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereIllinois
- Medicine recall Zemplar (paricalcitol) Injection, 5 mcg/mL CGMP Deviations: There is potential that Abbott’s third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lipitor (Atorvastatin calcium) Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereAlaska, Georgia and North Carolina
- Medicine recall Magnesium Sulfate in Water for Injection, 40 mg/mL Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate. Class IIIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count… Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC Lack of Assurance of Sterility: Bausch & Lomb, Inc. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carbon Dioxide, USP, Medical Gas Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereArizona and California
- 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 classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 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 classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 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 classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Daytrana (methylphenidate) transdermal system patch, Delivers 10 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 classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Octreotide Acetate Injection, 50 mcg/mL Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL… Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC… Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereKentucky and North Carolina
- Medicine recall DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione… Class IIIFDA’s classJun 20, 2012in FDA’s Enforcement ReportMainethe one state its words name PublishedJun 20, 2012ClassClass IIIStatusTerminatedWhereMaine
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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