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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 10,441–10,460 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09

by The Harvard Drug Group

Reason
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recall initiated
August 2, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

by The Harvard Drug Group

Reason
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recall initiated
August 2, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

by The Harvard Drug Group

Reason
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Recall initiated
August 2, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

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

by PD-Rx Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Recall initiated
August 11, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass I

CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987

by Brian P. Richardson

Reason
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk
Recall initiated
May 25, 2017
Reported by FDA
August 30, 2017
Distribution
TX

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Drug Recall Terminated Historical recordClass II

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

by C. O. Truxton

Reason
Labeling: Label Mixup; potentially mislabeled
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

by C. O. Truxton

Reason
Labeling: Label Mixup; potentially mislabeled
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031

by C. O. Truxton

Reason
Labeling: Label Mixup; potentially mislabeled
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10

by C. O. Truxton

Reason
Labeling: Label Mixup; potentially mislabeled
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10

by C. O. Truxton

Reason
Labeling: Label Mixup; potentially mislabeled
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

by C. O. Truxton

Reason
Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets
Recall initiated
April 20, 2017
Reported by FDA
August 30, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.

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 Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.

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 Perfect sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03320, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033200.

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 Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.

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 Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002.

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 terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500.

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 dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.

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 Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302.

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 sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.

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 →

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.