Medicines, 2014
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1,562 medicine recalls FDA’s Enforcement Report published in 2014, 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.
1,562of 1,562 medicine recallsshown with your filters
The list
- Medicine recall Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class IIIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zithromax (azithromycin for injection), 500 mg/vial, Sterile Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant. Class IIIFDA’s classJan 22, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle Presence of Foreign Substance; metal particulates were visually observed in the tablets. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC… Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Class IIIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 15, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Class IIIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 15, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle… Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Class IIIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 15, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Triple Mix Injectable (aka Dr Ungers Triple Rx Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Quad Mix Injectable, 5 mL Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medicine recall G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ) Failed Content Uniformity Specifications; at the 18 month time point. Class IIIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Daunorubicin Hydrochloride Injection, 20 mg/4 mL Presence of Precipitate; precipitation of drug product Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg Subpotent; Hydrochlorothiazide at the 9 month time point. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL… Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. Class IIIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 8, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle Failed Tablet/Capsule Specifications: There is a potential for broken tablets. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, Puerto Rico and US Virgin Islands named
- Medicine recall Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. Class IIIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 1, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite… Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxygen, Compressed USP, in an aluminum cylinder Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and contain no medical oxygen. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereMassachusetts, New Hampshire, New York and Vermont
- Medicine recall Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges… Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Oral Suspension, USP 200 mg/5 mL Failed Stability Specification; product viscosity and or pH are below specification. Class IIIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carisoprodol IV ( Carisoprodol Tablets USP) 350mg Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability… Class IIFDA’s classJan 1, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 1, 2014ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Missouri and North Carolina
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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