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 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine… Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Class IIIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall ARGATROBAN Injection CGMP Deviations Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Linezolid Injection 600 mg/300 mL CGMP Deviations Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Eptifibatide Injection 75 mg/100 mL CGMP Deviations Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ondansetron Injection USP 40 mg/20 mL CGMP Deviations Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Class IIIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000… Lack of Assurance of Sterility Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials Lack of Assurance of Sterility Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Remeven Cream Crystallization; Complaints that cream appears to have crystallized Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC… Crystallization; complaints received by the manufacturer of crystals forming in product Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine Besylate Tablets, USP, 2.5 mg* CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, USP, 5 mg* CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Amlodipine Besylate Tablets, USP, 10 mg* CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Desoximetasone Gel USP, 0.05% Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle Superpotent drug: Out of specification test result for assay during stability testing. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acetasol HC (hydrocortisone and acetic acid otic solution USP) Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability… Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Hydrocortisone and acetic acid otic solution Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability… Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 31, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Glipizide 2.5 mg Extended-release tablets, 30-count bottle Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle Failed Dissolution Specifications: Out-of-specification results in retained sample. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle Failed Dissolution Specifications: Out-of-specification results in retained sample. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine HCL ER Capsule USP, 150mg Failed Dissolution Specifications: out of specification dissolution results in retained samples Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine HCL ER Capsule USP, 75mg Failed Dissolution Specifications: out of specification dissolution results in retained samples Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zinc Acetate, Crystal, USP Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereGeorgia, Massachusetts, Missouri and Tennessee
- Medicine recall Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant… Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Children’s Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per… Failed Content Uniformity Specifications: out of specification test result for spray content uniformity. Class IIIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 10, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial… Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of… Class IIFDA’s classAug 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportIdahothe one state its words name PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereIdaho
- Medicine recall Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles Failed Dissolution Specifications Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles Failed Tablet/Capsule Specifications Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 3, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile,… Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution. Class IIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. Class IIIFDA’s classAug 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 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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