Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz CGMP Deviations Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg,… Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials. Class IIFDA’s classJul 6, 2016in FDA’s Enforcement ReportMississippithe one state its words name PublishedJul 6, 2016ClassClass IIStatusTerminatedWhereMississippi
- Medicine recall Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle Discoloration: presence of scuffing marks on tablets. Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing… Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis. Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ciprofloxacin Ophthalmic Solution Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the… Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity. Class IIIFDA’s classJul 6, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall tabcin ACTIVE M.R CGMP Deviations Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall tabcin NOCHE CGMP Deviations Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VERMOX Tablets 100 mg CGMP Deviations Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall VERMOX Tablets 500 mg, 1-count box CGMP Deviations Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 1% Clotrimazol cream, 30 mg tube CGMP Deviations Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg Chemical Contamination: Bottles may contain broken dessicants Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dicloxacillin Sodium Capsules, USP 250mg Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dicloxacillin Sodium Capsules USP, 500mg Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical… cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportColoradothe one state its words name PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereColorado
- Medicine recall VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle Defective delivery system: Softgel capsules are leaking. Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on… Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hectorol (doxercalciferol injection) 2 mcg/1mL Labeling: Wrong barcode. Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereMichigan, New Jersey and Pennsylvania
- Medicine recall Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL Failed Dissolution Specifications Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline, USP Capsules 40 mg Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing. Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine… Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial Presence of Particulate Matter: Cardboard Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only,… Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lisinopril Tablets USP, 30 mg, 100-count bottle Labeling: Incorrect or Missing Package Insert Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial Presence of Particulate Matter: Glass particulate found in sterile injectable product Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known… Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called “air shot” step Class IIFDA’s classJun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct… Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thin and Slim Fataway Ultimate Stack with Chromium Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall The People’s Chemist Thermo FX Barely Legal Thermogenic Aid Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MetaPro 360 Metabolic Accelerator Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thin and Slim Burn Fat Now Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall TruTrim (product not labeled) Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thin and Slim Naturally The Natural Alternative AM Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thin and Slim Extreme Stack Fat Burner Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 15, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2016ClassClass IStatusTerminatedWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.