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 Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles Subpotent Drug Class IIIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles Subpotent Drug Class IIIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin 1 mg/10 mL Subpotent Drug: found to be below the specification for labeled assay. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin Subpotent Drug: found to be below the specification for labeled assay. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin Subpotent Drug: found to be below the specification for labeled assay. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin 1 mg/10 mL Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NitroGlycerin Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall LaBri’s Body Health Atomic 60 Capsules Exclusively Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall LaBri’s Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri’s Body Health. Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin Hydrochloride for Injection, USP. 750 mg Presence of Particulate Matter: glass particulate found in vial FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10) Superpotent Class IIIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil… Labeling: Incorrect Instructions. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NATURAL HERBAL COFFEE AMPT Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ciprofloxacin in Dextrose Superpotent Class IIIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper… Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only… Stability Date Doesn’t Support Expiry: labeling error indicating a beyond use date that exceeds current stability data. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereFlorida, Maryland, Michigan, Minnesota, North Carolina and Ohio
- Medicine recall All Sterile Products within expiry Lack of Assurance of Sterility . Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Penicillin V Potassium for Oral Solution, USP, 125 mg Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities. Class IIIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 20, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl Microbial Contamination of Non-Sterile Products Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 13, 2017ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw… Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 13, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 13, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Isradapine Capsules USP 2.5 mg, 100-count bottles Failed Impurities/Degradation Specifications Class IIIFDA’s classDec 13, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 13, 2017ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall No.1 Faiza Beauty Cream Marketed Without an Approved NDA/ANDA Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Clozapine Tablets USP, 100 mg, 500 count bottles Failed Tablet/Capsule Specifications; potential presence of broken tablets. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles Failed Dissolution Specification Class IIIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles Failed Dissolution Specifications. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Oral Solution, USP, 100 mg/mL Presence of foreign substance (screw) Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNew Jersey
- Medicine recall Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide… CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity. Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000… Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets Class IIFDA’s classDec 6, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 6, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL CGMP Deviations Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedNov 29, 2017ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall No. 1 Faiza Beauty Cream Marketed Without an Approved NDA/ANDA Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle Labeling: Label Error on Declared Strength. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC… GMP Deviations: inadequate manufacturing control processes Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC… GMP Deviations: inadequate manufacturing control processes Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC… GMP Deviations: inadequate manufacturing control processes Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC… GMP Deviations: inadequate manufacturing control processes Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC… GMP Deviations: inadequate manufacturing control processes Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Paroxetine Tablets, USP, 30mg, 100 tablets Presence of Foreign Tablets/Capsules. Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was… Class IIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01) Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). Class IIIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). Class IIIFDA’s classNov 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 29, 2017ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico 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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