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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 981–1000 of 1,000 recalls

Class IIITerminated

Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05

Actavis Inc

Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.

February 7, 2017 · DrugView details →
Class IIITerminated

Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.

Sage Products Inc

Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.

February 2, 2017 · DrugView details →
Class IIITerminated

Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.

Mylan Pharmaceuticals Inc.

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

January 30, 2017 · DrugView details →
Class IIITerminated

Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.

Mylan Pharmaceuticals Inc.

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

January 30, 2017 · DrugView details →
Class IIITerminated

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466

Pharmedium Services, LLC

Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

January 27, 2017 · DrugView details →
Class IIITerminated

Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.

LEO PHARMA INC

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

January 16, 2017 · DrugView details →
Class IIITerminated

DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Failed Impurities/ Degradation Specifications

January 16, 2017 · DrugView details →
Class IIITerminated

Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53

Actavis Inc

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

January 12, 2017 · DrugView details →
Class IIITerminated

Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30

Hetero USA Inc

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

January 7, 2017 · DrugView details →
Class IIITerminated

Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284

InnovaGel

Subpotent

January 5, 2017 · DrugView details →
Class IIITerminated

Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284

InnovaGel

Subpotent

January 5, 2017 · DrugView details →
Class IIITerminated

Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10

Mckesson Packaging Services

Supotent: Out of Specification result for assay test during routine stability testing.

January 4, 2017 · DrugView details →
Class IIITerminated

Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90

Hetero Drugs Ltd. - Unit 1

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

December 29, 2016 · DrugView details →
Class IIITerminated

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04

The Harvard Drug Group

Superpotent Drug; out of specification results for assay (manufacturer)

December 27, 2016 · DrugView details →
Class IIITerminated

TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Failed Stability Specifications

December 22, 2016 · DrugView details →
Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications; 18 month stability time point

December 20, 2016 · DrugView details →
Class IIITerminated

buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86

Sun Pharmaceutical Industries, Inc.

Failed Dissolution Specifications; 18 month stability time point

December 20, 2016 · DrugView details →
Class IIITerminated

Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.

Apotex Inc.

Superpotent Drug: Product may not meet specifications throughout shelf life.

December 19, 2016 · DrugView details →
Class IIITerminated

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

Aurobindo Pharma USA Inc

Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

December 16, 2016 · DrugView details →
Class IIITerminated

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99

Roxane Laboratories, Inc.

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

December 14, 2016 · DrugView details →
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