Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugGaia Ethnobotanical LLCClass IGaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, Gaia Ethnobotanical.com
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
- 2018-07-18FDA-DrugMylan Pharmaceuticals Inc.Class IIITriamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Subpotent Drug
- 2018-07-18FDA-DrugLUPIN SOMERSETClass IINitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
Subpotent Drug and Failed Content Uniformity.
- 2018-07-18FDA-DrugSanofi-Aventis U.S. LLCClass IIAdmelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
- 2018-07-18FDA-DrugMedi-Fare Drug and Home Health CenterClass IIPotassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
- 2018-07-18FDA-DrugSCA PharmaceuticalsClass IIBuffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
- 2018-07-18FDA-DrugMedgyn Products, Inc.Class IIMonsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
- 2018-07-18FDA-DrugAkorn, Inc.Class IIAcetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
CGMP Deviations
- 2018-07-18FDA-DrugAMERICAN HEALTH PACKAGINGClass IIIEnalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-390-01 Carton [68084-390-11 - Unit Dose]
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
- 2018-07-18FDA-DrugWockhardt LimitedClass IIIEnalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
Failed Impurities/Degradation Specifications
- 2018-07-18FDA-DrugWockhardt LimitedClass IIIEnalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
Failed Impurities/Degradation Specifications
- 2018-07-18FDA-DrugTeva Pharmaceuticals USAClass IIFluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
- 2018-07-11FDA-DrugFagron Compounding Services LLC dba Fagron Sterile ServicesClass INeostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- 2018-07-11FDA-DrugFagron Compounding Services LLC dba Fagron Sterile ServicesClass INeostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
- 2018-07-11FDA-DrugEb5 CorporationClass IIeb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
- 2018-07-11FDA-DrugLUPIN SOMERSETClass IIIEquate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IIPhenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IIPhenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IIPhenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IIPhenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IIPhenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
- 2018-07-11FDA-DrugSCA Pharmaceuticals, LLCClass IINorepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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