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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 6,981–7,000 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass I

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

by Green Lumber Holdings, LLC

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Recall initiated
October 22, 2019
Reported by FDA
November 13, 2019
Distribution
United States and Canada. Only email addresses were provided, no physical address information was received.

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Drug Recall Terminated Historical recordClass I

0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25

by ICU Medical Inc

Reason
Presence of Particulate Matter.
Recall initiated
October 25, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass I

LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03

by ICU Medical Inc

Reason
Presence of Particulate Matter.
Recall initiated
October 25, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass III

Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Recall initiated
November 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.

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Drug Recall Terminated Historical recordClass III

Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Recall initiated
November 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.

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Drug Recall Terminated Historical recordClass III

Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign substance: identified as a dead ant.
Recall initiated
November 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors/wholesalers throughout the United States.

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Drug Recall Terminated Historical recordClass III

Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.

by Sato Pharmaceutical Inc.

Reason
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA and Guam and Saipan, Northern Mariana Islands

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Drug Recall Terminated Historical recordClass II

S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG/8.88MCG/ML) INJ: l) S-TRIMIX-104 (30MG/2MG/20MCG/ML) MDV: m) S-TRIMIX-DS (16.67MG/0.58MG/17.7MCG/ML) MDV: Rx Only, 5ml glass vial. Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason
Lack of Assurance of Sterility
Recall initiated
August 12, 2019
Reported by FDA
November 13, 2019
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.