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 Lightning ROD capsules, 550 mg/capsule Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC,… Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Warfarin Sodium Tablets, USP 2 mg Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereGeorgia
- Medicine recall MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial Presence of Precipitate; potential for incomplete constitution upon addition of diluent. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 14, 2013ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Rifadin, Rifampin capsules, 150 mg Subpotent drug: low fill volume in some of the capsules Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Terazosin Hydrochloride Capsules,10 mg, 100-count bottle Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in… Defective container: products are packaged in pouches which may not have been fully sealed Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets Defective container: products are packaged in pouches which may not have been fully sealed Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall No Doz, Max Strength Defective container: products are packaged in pouches which may not have been fully sealed Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg) Defective container: products are packaged in pouches which may not have been fully sealed Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets,… Presence of Foreign Tablets/Capsules: Product labeled TUMS Ultra Assorted Berries 1000mg Chewable tables, may contain EX TUMS Assorted Berries 750mg tablets Class IIIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ondansetron Injection, USP, 4mg/2mL Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Latanoprost Ophthalmic Solution, 0.005% Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets, USP, 2.5 mg Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is… Class IIIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits. Class IIIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet Failed Impurities/Degradation Specifications: unspecified degradation product Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine… Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereGeorgia
- Medicine recall DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil… Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Night Bullet Capsules, supplied Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL Failed Impurity/Degradation Specification; “Related Compound C” Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine Tablets, USP, 10 mg Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DIANEAL Low Calcium Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast… Presence of Particulate Matter; particulate found in retain samples Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC… Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Magnesium Sulfate 2 grams in Dextrose 5% for Injection Non-Sterility; mold contamination FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Delaware, Florida, Illinois, Indiana, Maine, Michigan, New Jersey, Pennsylvania, Texas and Virginia named
- Medicine recall All Compounded Products Lack of Assurance of Sterility; potential for mold contamination Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Delaware, Florida, Illinois, Indiana, Maine, Michigan, New Jersey, Pennsylvania, Texas and Virginia named
- Medicine recall ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia… Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam named
- Medicine recall LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle Failed Tablet/Capsule Specifications: Broken tablets Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only Lack of Assurance of Sterility; Astellas Pharma US, Inc. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained… Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b)… Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2013ClassClass 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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