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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 10,461–10,480 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.

by Linde Eckstein Gmbh + Co KG

Reason
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recall initiated
July 17, 2017
Reported by FDA
August 23, 2017
Distribution
Distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass III

Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005.

by Linde Eckstein Gmbh + Co KG

Reason
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recall initiated
July 17, 2017
Reported by FDA
August 23, 2017
Distribution
Distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass III

Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.

by Linde Eckstein Gmbh + Co KG

Reason
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recall initiated
July 17, 2017
Reported by FDA
August 23, 2017
Distribution
Distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass III

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.

by Linde Eckstein Gmbh + Co KG

Reason
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recall initiated
July 17, 2017
Reported by FDA
August 23, 2017
Distribution
Distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass III

Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.

by Linde Eckstein Gmbh + Co KG

Reason
Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Recall initiated
July 17, 2017
Reported by FDA
August 23, 2017
Distribution
Distributed throughout the United States

View recall →

Drug Recall Terminated Historical recordClass II

Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076

by Global Marketing Enterprises, Inc.

Reason
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Recall initiated
May 22, 2017
Reported by FDA
August 23, 2017
Distribution
KY, VA, MI

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Drug Recall Terminated Historical recordClass II

Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30

by Hetero USA Inc

Reason
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Recall initiated
July 20, 2017
Reported by FDA
August 23, 2017
Distribution
NJ

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Drug Recall Terminated Historical recordClass III

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

by AVKARE Inc.

Reason
Failed impurities/degradation specifications: Out of specification for a related compound C.
Recall initiated
July 19, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202

by Lupin Limited (Unit 1)

Reason
Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.
Recall initiated
May 16, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842

by Genetic Edge Compounds LLC

Reason
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.
Recall initiated
May 5, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09

by ICU Medical Inc

Reason
Presence of Particulate Matter; stainless steel
Recall initiated
July 26, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014

by Akorn Inc

Reason
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recall initiated
July 12, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012

by Akorn Inc

Reason
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recall initiated
July 12, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

by Akorn Inc

Reason
Crystallization with subpotent out of specification assay results for chlorhexidine.
Recall initiated
July 12, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004

by DYNAMIC TECHNICAL FORMULATIONS

Reason
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.
Recall initiated
May 19, 2017
Reported by FDA
August 23, 2017
Distribution
U.S.A. nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

by Amgen, Inc.

Reason
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Recall initiated
August 4, 2017
Reported by FDA
August 23, 2017
Distribution
United States including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1

by HARDCORE FORMULATIONS

Reason
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Recall initiated
July 5, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

by HARDCORE FORMULATIONS

Reason
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Recall initiated
July 5, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

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

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Recall initiated
August 3, 2017
Reported by FDA
August 23, 2017
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 vials per case (NDC 0703-0113-03) Mfd By: Hospira, Inc., Lake Forest, IL 60045 USA, Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618 USA.

by HOSPIRA INC, LAKE FOREST

Reason
Presence of Particulate Matter: Silicone oil
Recall initiated
July 26, 2017
Reported by FDA
August 16, 2017
Distribution
Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.