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 0.9% Sodium Chloride Injection, USP, a) 50 mL (NDC 0409-7984-13), b) 50 mL (NDC 0409-7984-36), c) 100 mL Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Oregon and Washington named
- Medicine recall INK-EEZE Tattoo Numbing Spray, 2 oz. Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereCalifornia and Colorado
- Medicine recall INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereCalifornia and Colorado
- Medicine recall 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL. Class IIFDA’s classJul 3, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 3, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Sulfacetamide 10% and Sulfur 5% Lotion, (NDC 42792-102-01), 25 g Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength. Class IIIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl Subpotent; 24 month stability test station Class IIIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dr. Sheffield’s Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate… Failed Stability Specifications: Unable to meet shelf life expiry. Class IIIFDA’s classJun 26, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 26, 2013ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Pennsylvania and Washington
- Medicine recall VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single… CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a… Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01),… Failed Dissolution Specification; during stability testing Class IIFDA’s classJun 26, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereFlorida, Illinois, Massachusetts, Missouri, Mississippi, Ohio and Texas
- Medicine recall Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg Failed Dissolution Specification Class IIIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial. Class IIFDA’s classJun 26, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked… Class IIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amoxicillin for Oral Suspension, USP 400mg/5mL Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. Class IIIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54) Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied Marketed Without an Approved NDA/ANDA: product contains sibutramine, a previously approved FDA drug removed from the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 19, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate, 5 gr Labeling; Label Mixup; bottles of Ferrous Sulfate actually contains Meclizine HCl (indicated for motion sickness) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE… Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall AMBI 40PSE/400GFN, 100 tablet bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste… CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Lusair Liquid, 1 PINT bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
- Medicine recall Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class IIFDA’s classJun 12, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 12, 2013ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Mississippi, South Carolina and Texas
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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