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 Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network Superpotent and Subpotent drugs Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportTennesseethe one state its words name PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care… Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione. Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clonazepam Tablets, USP, 0.5 mg Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint. Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clonazepam Tablets, USP, 1.0 mg Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint. Class IIIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Desoximetasone Cream USP, 0.25% 100 g Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 9, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Desoximetasone Cream USP, 0.05% 100 g Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation). Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 9, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Ramipril Capsules, USP, 1.25 mg, 30-count bottle Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17. Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3… Subpotent Drug; Ethinyl Estradiol Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3… Subpotent Drug; Ethinyl Estradiol Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate… Subpotent Drug; Ethinyl Estradiol Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous… Subpotent Drug; Ethinyl Estradiol Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous… Subpotent Drug; Ethinyl Estradiol Class IIIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIIStatusCompletedWhereNationwide, and Puerto Rico named
- Medicine recall Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL Subpotent Drug: concentration of product is less than labeled amount. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm’s process media validation. Class IIFDA’s classNov 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100… Class IIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the… Class IIIFDA’s classNov 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 2, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNew York
- Medicine recall Ninja-X, 4200 mg, 1 capsule per pack, 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNew York
- Medicine recall Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNew York
- Medicine recall Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box. Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 26, 2016ClassClass IStatusTerminatedWhereNew York
- Medicine recall Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 26, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedOct 26, 2016ClassClass IStatusTerminatedWhereCalifornia, Florida, Georgia, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia
- Medicine recall Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Dream Body 450 mg 30 capsules in a plastic screw on top bottle Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Dream Body Advanced 400 mg 30 capsules in brown foil packets. Marketed without an approved NDA/ANDA: Undeclared sibutramine. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall PARICALCITOL Capsules, 1 mcg, 30-count bottles Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Class IIIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PARICALCITOL Capsules, 2 mcg, 30-count bottles Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Class IIIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PARICALCITOL Capsules, 4 mcg, 30-count bottles Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing. Class IIIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 26, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack Superpotent Drug: Failure of assay specifications in the capsule. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Paricalcitol Capsules, 1 mcg Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities. Class IIIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate 0.01% Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brilliant Blue G 0.025% Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefuroxime Sodium 10 mg/mL Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin 0.02% Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter’s… Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin 10 mg/mL Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall La’ Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNo state named
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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