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 TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 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 TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 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 TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 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 TROPICAMIDE OPHTHALMIC P.F. 1% SOLUTION 30 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 TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 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 TRYPAN BLUE SOLUTION, P.F. 0.04% 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 TWINJECT*** 0.3 MG INJECTABLE 1 PK 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 ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS… 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 VANADYL SULFATE SOLUTION 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
- Medicine recall VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% 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 VANCOMYCIN/DEXAMETHASONE, LYOPHILIZED 1%/0.1% KIT 2 KIT 20 KIT 24 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 VERAPAMIL HCL 10MG/ML INJECTABLE 80 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 VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 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 VORICONAZOLE OPHTHALMIC 1% 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 WATER BACT STERILE 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 ZINC CHLORIDE 10MG/ML INJECTABLE 30 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 Topiramate Tablets, 50 mg, 30-count Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 “Capsules” (3 x 10) rather than… Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz Subpotent; fluocinolone acetonide Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl Subpotent; fluocinolone acetonide Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b)… Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. Class IIIFDA’s classAug 22, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 22, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meloxicam Tablets, USP, 15 mg Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6… CGMP Deviations; no identity or purity testing on incoming oxygen gas, and lack of documentation Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportOklahomathe one state its words name PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count Lack of Assurance of Sterility Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metformin Hydrochloride Tablets, USP, 1000 mg Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Argatroban Injection 50 mg per 50ml A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 8, 2012in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedAug 8, 2012ClassClass IStatusTerminatedWhereNew Jersey
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found. Class IIIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall OFIRMEV (acetaminophen) injection, 1000 mg/100 mL Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Hemihydrate M20 EP/USP Powder Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereCalifornia and Kansas
- Medicine recall Dr. Reddy’s Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr.… Adulterated Presence of Foreign Tablets: Dr. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dr. Reddy’s Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy’s Laboratories… Adulterated Presence of Foreign Tablets: Dr. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125… Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. Class IIIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application… Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Major brand Infants’ Mapap, Acetaminophen Concentrated Drops, 1 FL Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Class IIIFDA’s classAug 8, 2012in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 8, 2012ClassClass IIIStatusTerminatedWhereMichigan
- Medicine recall Dent’s Extra Strength Toothache Gum, (benzocaine 20%) Superpotent; benzocaine Class IIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product. Class IIIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label. Class IIIFDA’s classAug 1, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 1, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point. Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Prefera OB One Gel Capsules, 30 softgels Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this… Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL Labeling: Label Mix-up: Pitocin storage conditions should be labeled, “Store between 20¿ to 25¿C (68¿ to 77¿F)”. Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 25, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Epinephrine Injection, USP, 1:1000 Presence of Particulate Matter Class IIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ciprofloxacin Tablets, USP, 500 mg Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels. Class IIIFDA’s classJul 25, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 25, 2012ClassClass 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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