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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 881–900 of 1,000 recalls

Class IIITerminated

Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Terminated

Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

Wells Pharmacy Network, LLC

Superpotent and Subpotent drugs

September 19, 2016 · DrugView details →

Class IIITerminated

Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10

Mckesson Packaging Services

Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).

September 15, 2016 · DrugView details →

Class IIITerminated

PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91

Pfizer Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.

September 15, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications

September 13, 2016 · DrugView details →

Class IIITerminated

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

September 13, 2016 · DrugView details →

Class IIITerminated

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

Pfizer Inc.

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

September 9, 2016 · DrugView details →

Class IIITerminated

Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10

Mckesson Packaging Services

Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.

September 8, 2016 · DrugView details →

Class IIITerminated

Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01

Biocompatibles U.K., Ltd.

Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack

September 7, 2016 · DrugView details →

Class IIITerminated

Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10

Shire

Presence of Foreign Tablets/Capsules

September 2, 2016 · DrugView details →

Class IIITerminated

Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx Only, Manufactured by: Genzyme Corporation 500 Kendall Street, Cambridge, MA 02412 USA NDC: 0024-5862-01

Sanofi-Aventis U.S. LLC

Labeling: Incorrect or Missing Package Insert

September 1, 2016 · DrugView details →

Class IIITerminated

ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81

Dr. Reddy's Laboratories, Inc.

Failed Dissolution Specifications

August 29, 2016 · DrugView details →

Class IIITerminated

Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06

Stason Pharmaceuticals, Inc.

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

August 23, 2016 · DrugView details →

Class IIITerminated

Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.

Unichem Pharmaceuticals Usa Inc

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

August 19, 2016 · DrugView details →

Class IIITerminated

Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,

West-Ward Pharmaceuticals Corp.

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

August 18, 2016 · DrugView details →

Class IIITerminated

Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86

Teva North America

Failed Impurities/Degradation Specifications.

August 5, 2016 · DrugView details →

Class IIITerminated

buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

Amerisource Health Services

Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

August 4, 2016 · DrugView details →

Class IIITerminated

Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01

Genzyme Corporation / Genzyme Biosurgery

Labeling: Incorrect or Missing Lot and/or Exp. Date

August 4, 2016 · DrugView details →

Class IIITerminated

Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60

Reckitt Benckiser LLC

Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.

August 3, 2016 · DrugView details →

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