Drug and pharmaceutical recalls
17730 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-12-07FDA-DrugPar Pharmaceutical, Inc.Class IITravoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
- 2016-11-30FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIPhenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
- 2016-11-30FDA-DrugHospira Inc.Class IIFentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
- 2016-11-30FDA-DrugAkorn IncClass IIDesoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
- 2016-11-30FDA-DrugMylan Pharmaceuticals Inc.Class IIIDiltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Failed Impurities/Degradation Specifications: OOS results for known compound.
- 2016-11-30FDA-DrugPfizer Inc.Class IILEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01
Superpotent
- 2016-11-30FDA-DrugZydus Pharmaceuticals USA IncClass IIIBuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
- 2016-11-30FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIKENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
- 2016-11-30FDA-DrugWest-Ward Pharmaceuticals Corp.Class IIIAmoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
- 2016-11-30FDA-DrugVistaPharm, Inc.Class IILactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
- 2016-11-30FDA-DrugSandoz IncClass IIICeftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
Labeling: Missing Label
- 2016-11-30FDA-DrugAmerisource Health ServicesClass IIIAHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217
Presence of Foreign Tablets/Capsules
- 2016-11-30FDA-DrugActavis Elizabeth LLCClass IIINIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
Presence of Foreign Tablets/Capsules
- 2016-11-23FDA-DrugGSK Consumer HealthcareClass IIIZeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
- 2016-11-23FDA-DrugSandoz IncClass IIL-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- 2016-11-23FDA-DrugSandoz IncClass IIL-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
- 2016-11-23FDA-DrugCutisPharma, Inc.Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- 2016-11-23FDA-DrugCutisPharma, Inc.Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
- 2016-11-23FDA-DrugAmerisource Health ServicesClass IIIBupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
- 2016-11-16FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIClonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
- 2016-11-16FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IIIClonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
- 2016-11-16FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class IIIKamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
- 2016-11-16FDA-DrugSandoz IncClass IITransderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIIEstradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIIEstradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIITestosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IIITestosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
- 2016-11-16FDA-DrugWells Pharmacy Network, LLCClass IITestosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Superpotent and Subpotent drugs
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