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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 12,921–12,940 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

by the Compounder

Reason
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Recall initiated
March 10, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10

by Breckenridge Pharmaceutical, Inc

Reason
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Recall initiated
October 21, 2015
Reported by FDA
November 18, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

by Pacific Healthcare, Inc dba B&B Pharmacy

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
October 7, 2015
Reported by FDA
November 18, 2015
Distribution
CA and NJ

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.