Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 0.2%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 0.5%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 1%, Rx, plastic dropper bottle
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIVitamin B12 liquid 1000mcg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IITestosteron Cypionate liquid 200mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIMethocarbamol liquid 100mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIMIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IILidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include injectable medications, sterile solutions, eye drops, and eye ointments
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IILidocaine gel 2%, RX, plastic dropper
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIHydroxyprogesterone liquid, 250mg/ml, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIHCG liquid, 1000u/ml, RX, glass vial, various
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIGlutathione liquid, 100mg/ml
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IIEpinephrine liquid 1:1000, RX, glass vial
Lack of sterility assurance.
- 2019-01-09FDA-DrugHiers Enterprises, LLC dba Northwest Compounding PharmacyClass IICyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye
Lack of sterility assurance.
- 2019-01-09FDA-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, NDC 43386-450-11.
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- 2019-01-02FDA-DrugAdvanced Pharma Inc.Class IPhenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 10 mL syringe, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, (877) 794-0404; NDC: 42852-802-61.
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
- 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.
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