Medicines, 2017
Shortlist up to four to read them side by side.
1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC… Failed Dissolution Specifications; 18 month stability time point Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles Failed Dissolution Specifications; 18 month stability time point Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. Class IIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedFeb 1, 2017ClassClass IIStatusTerminatedWhereMinnesota
- Medicine recall Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point.. Class IIIFDA’s classFeb 1, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 1, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19) Failed Dissolution Specifications Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Novacort Gel Sample Packets Subpotent Drug: Out of specification result for pramoxine hydrochloride Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap Class IIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Donepezil Hydrochloride Tablets, 10 mg Subpotent Drug: out of specification results for assay test. Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial Subpotent Drug: due to failed potency results of 74% (spec. Class IIIFDA’s classJan 25, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 25, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months Class IIIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package Discoloration: there were customer reports of yellow discolored solution. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states “in grapeseed oil” instead of “in sesame oil” . Class IIIFDA’s classJan 18, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 18, 2017ClassClass IIIStatusTerminatedWhereArizona and Washington
- Medicine recall HCG-Vitamin B12 5000 IU-8 mg Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. Class IIIFDA’s classJan 18, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 18, 2017ClassClass IIIStatusTerminatedWhereArizona and Washington
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values. Class IIFDA’s classJan 18, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 18, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gentell Hydrogel Ag Saturated Gauze, 2”x2”(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4”x8”(NDC… CGMP Deviations Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Gentell Hydrogel Wound Dressing REGULAR, 4 oz CGMP Deviations Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Torsemide Tablets, 20 mg 100-count bottle CGMP Deviations Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Torsemide Tablets, 5 mg 100-count bottle CGMP Deviations Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 11, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Amino Energy Cocktail Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amino Acid Recover Eaze Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ascorbic Acid 500 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocaine HCL 10 mg/mL). Compounded by… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BiMix Phentolamine/Papaverine 1 mg/30 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall BiMix Phentolamine/Papaverine 2 mg/30 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Calcium Gluconate 10% Injection Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dexpanthenol 250 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glucosamine 200 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glutamine 25 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glutathione 200 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HCG 5,000 IU Vial Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HCG/Hydroxycobalamin 5,000 IU/5 mg Vial Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HCG 11,000 IU Vial Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall L-Arginine HCL 100 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall L-Carnitine 250 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall L-Tyrosine 10 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) 100 mg/Methylcobalamin 1… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-phosphate Sod 2… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg +… Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL Lack of Assurance of Sterility Class IIFDA’s classJan 11, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2017ClassClass IIStatusOngoingWhereNationwide
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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