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.
- 2019-01-02FDA-DrugAmerigen Pharmaceuticals Inc.Class IIITemozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
Failed Dissolution Specifications
- 2019-01-02FDA-DrugAmerigen Pharmaceuticals Inc.Class IIITemozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
Failed Dissolution Specifications
- 2018-12-26FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIAbsorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
- 2018-12-26FDA-DrugCipla LimitedClass IINevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
Failed Dissolution Specifications.
- 2018-12-26FDA-DrugResults RNA, LLCClass ILubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
- 2018-12-26FDA-DrugAsclemed USA Inc. dba EnovachemClass IDyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
- 2018-12-26FDA-DrugAsclemed USA Inc. dba EnovachemClass IDyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
- 2018-12-26FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIIAprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
- 2018-12-26FDA-DrugVistaPharm, Inc.Class IIINYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Failed Impurities/Degradation Specifications:Out of specification for impurities.
- 2018-12-26FDA-DrugPharm D Solutions, LLCClass IIHuman Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-12-26FDA-DrugCBI Laboratories, Inc.Class IIIOptions Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
- 2018-12-26FDA-DrugCBI Laboratories, Inc.Class IIIAdvanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
- 2018-12-26FDA-DrugKVK-Tech, Inc.Class IIOxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Labeling: Wrong bar code
- 2018-12-26FDA-DrugPfizer Inc.Class IILevoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01
Superpotent Drug.
- 2018-12-26FDA-DrugGordon LaboratoriesClass IIMonsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Superpotent Drug: contains higher levels of Iron than labeled.
- 2018-12-26FDA-DrugTris Pharma Inc.Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- 2018-12-26FDA-DrugTris Pharma Inc.Class IIInfants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- 2018-12-26FDA-DrugTris Pharma Inc.Class IIinfants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
- 2018-12-26FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
Sub-potent
- 2018-12-26FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Sub-potent
- 2018-12-26FDA-DrugGE Healthcare Inc. Life SciencesClass IIOmnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
- 2018-12-26FDA-DrugEpic Pharma, LLCClass IIEstradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
- 2018-12-19FDA-DrugMylan Laboratories Limited, (Nashik FDF)Class IIValsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
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