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 6, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Furosemide Injection USP Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Isoniazid Tablets 300 mg tablets USP Failed Dissolution Specifications; 36 month stability timepoint Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereGeorgia
- Medicine recall buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. Class IIIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24… Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label. Class IIIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Citalopram tablets USP, 10mg, 30-count bottle Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Citalopram tablets USP, 20mg, 30-count bottle Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Citalopram tablets USP, 40mg, 30-count bottle Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA. Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL Cross Contamination with Other Products: Product was mixed with another type of mouth wash. Class IIIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Propofol Injectable Emulsion, 1% Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules Failed Dissolution Test Requirements Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medicine recall 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lac-Hydrin (ammonium lactate) Lotion, 12% Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. Class IIIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 20, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lac-Hydrin (ammonium lactate) Cream, 12% Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product. Class IIIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 20, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glycopyrrolate Tablets, USP, 1 mg Subpotent Drug Class IIIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportOhiothe one state its words name PublishedFeb 20, 2013ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereCalifornia and Virginia
- Medicine recall Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm Labeling: Incorrect or missing lot and/or expiration date. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Class IIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall EstroGel (estradiol gel) 0.06%, contained Defective Container: Pump head detaching from the canister unit upon removal of the overcap. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. Class IIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SLIM XTREME Herbal Slimming Capsule, supplied Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PredniSONE Tablets, USP, 10 mg Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets. Class IIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Carisoprodol Tablets, USP, 350 mg Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. Class IIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum… Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less… Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral… Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carboplatin Injection, 600 mg/60 mL Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Carboplatin Injection, 450 mg/45 mL Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC… Presence of Particulate Matter; fibers identified as cellulose and polyvinyl FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe Presence of Particulate Matter; fibers identified as cellulose and polyvinyl FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. Class IIFDA’s classFeb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 6, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected… Class IIFDA’s classFeb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle,… Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria. Class IIFDA’s classFeb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Femtrace 0.9 mg (Estradiol Acetate) Tablets Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Class IIIFDA’s classFeb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Femtrace 0.45 mg (Estradiol Acetate) Tablets Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles Class IIIFDA’s classFeb 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets, USP 40 mg Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel… Class IIFDA’s classJan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Propylthiouracil Tablets, USP, 50 mg Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron… Class IIFDA’s classJan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets. Class IIFDA’s classJan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PredniSONE Tablets, USP, 20 mg Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum… Class IIFDA’s classJan 30, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month… Class IIIFDA’s classJan 30, 2013in FDA’s Enforcement ReportMichiganthe one state its words name PublishedJan 30, 2013ClassClass IIIStatusTerminatedWhereMichigan
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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