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 5, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life. Class IIIFDA’s classDec 14, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedDec 14, 2016ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. Class IIIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing. Class IIIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. Class IIIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon… Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNew York
- Medicine recall PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon… Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Range Trauma Kit Hardcase Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Range Trauma Kit ORG Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Range Trauma Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Advance Trauma Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall K-9 Trauma Field Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amphibious Trauma Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mini Resupply Trauma Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aid Backpack Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall USCG Boat Response Kit Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic… CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP Class IIFDA’s classDec 7, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, South Carolina and Tennessee
- Medicine recall Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 Microbial Contamination of Non-Sterile Product Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Salsalate Tablets, USP, 500 mg CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Salsalate Tablets, USP, 750 mg CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NIFEdipine Capsules USP, 10 mg Presence of Foreign Tablets/Capsules Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01) Presence of Foreign Tablets/Capsules Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials Labeling: Missing Label Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereWisconsin
- Medicine recall Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01) Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted) Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP Failed Stability Specifications: Low Out of Specification results for alcohol content. Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNationwide, and New Jersey named
- Medicine recall BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point. Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles Superpotent Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle… Failed Impurities/Degradation Specifications: OOS results for known compound. Class IIIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60 Failed Stability Specifications; out-of specification value for homogeneity / phase separation. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenobarbital Tablets, USP 60mg 100=count bottles Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point Class IIFDA’s classNov 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b)… Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz. Labeling: Label error on declared strength. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ Labeling: Label error on declared strength. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01) Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zeasorb AF (miconazole nitrate), 2%, cures most athlete’s foot Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the… Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
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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