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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 861–880 of 1,000 recalls

Class IIITerminated

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1

Taro Pharmaceuticals U.S.A., Inc.

Cross contamination with other products: traces of Dapsone were found in the finished product.

September 20, 2017 · DrugView details →
Class IIITerminated

Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405

Vi-Jon, Inc.

Failed Impurities/Degradation Specifications.

September 13, 2017 · Drug
View details →
Class IIITerminated

Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC # 0363001726, UPC # 049022889125

Vi-Jon, Inc.

Failed Stability Specifications

September 13, 2017 · DrugView details →
Class IIITerminated

Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon One Swan Drive Smyrna, TN 37167, NDC 0869066738, UPC 308690667382; c) GoodSense, Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, NDC 50804-667-38, UPC 846036007374; d) Leader, Distributed By: Cardinal Health, Dublin, Ohio, 43017, NDC 3720511038, UPC 096295382433; e) Signature Care, Distributed By: Better Living Brands, LLC. P.O. Box 99, Pleasanton, CA 94566-0009, NDC 21130-667-38, UPC 321130779155; f) Discount Drug Mart Food Fair, Distributed By: Drug Mart-Food Fair Medina, Ohio 44256, NDC 5394301077, UPC 093351100383; g) Sunmark, Distributed By McKesson One Post Street San Francisco, CA 94104, NDC 4934869649, UPC 010939112330, h) Major, Distributed By: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA, NDC 0904630477, UPC 309046304777

Vi-Jon, Inc.

Failed Impurities/Degradation Specifications.

September 13, 2017 · DrugView details →
Class IIITerminated

AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30

AbbVie Inc.

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

September 8, 2017 · DrugView details →
Class IIITerminated

AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33

AbbVie Inc.

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

September 8, 2017 · DrugView details →
Class IIITerminated

Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30

Aidarex Pharmaceuticals LLC

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

September 5, 2017 · DrugView details →
Class IIITerminated

ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.

Aidarex Pharmaceuticals LLC

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

September 5, 2017 · DrugView details →
Class IIITerminated

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

Amerisource Health Services

Failed Stability Specifications

August 29, 2017 · DrugView details →
Class IIITerminated

Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

Mckesson Packaging Services

Failed moisture limits: Out of specification for moisture content.

August 28, 2017 · DrugView details →
Class IIITerminated

Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;

Wockhardt Usa Inc.

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

August 22, 2017 · DrugView details →
Class IIITerminated

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

VistaPharm, Inc.

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

August 17, 2017 · DrugView details →
Class IIITerminated

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

PD-Rx Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

August 11, 2017 · DrugView details →
Class IIITerminated

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL total volume (When constituted with 131 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-25.

Pfizer Inc.

Failed Dissolution Specifications

August 4, 2017 · DrugView details →
Class IIITerminated

Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL total volume (When constituted with 105 mL of water, 25 mg/5 mL (5 mg/mL) when reconstituted, Rx Only, Distributed by Nextwave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc., New York, NY 10017, Manufactured by Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 24478-200-20.

Pfizer Inc.

Failed Dissolution Specifications

August 4, 2017 · DrugView details →
Class IIITerminated

Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940

KVK-Tech, Inc.

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

August 3, 2017 · DrugView details →
Class IIITerminated

Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15

Teva Pharmaceuticals USA

Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

August 2, 2017 · DrugView details →
Class IIITerminated

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.

Teva Pharmaceuticals USA

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

July 25, 2017 · DrugView details →
Class IIITerminated

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

AVKARE Inc.

Failed impurities/degradation specifications: Out of specification for a related compound C.

July 19, 2017 · DrugView details →
Class IIITerminated

Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.

Linde Eckstein Gmbh + Co KG

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

July 17, 2017 · DrugView details →
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