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Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,138 FDA drug recalls.

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DateProductReasonClassFirm
Mar 10, 2015 ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transderma... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Proge... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate)... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) ... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Proge... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronize... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue U... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Tra... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenu... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN P... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TE... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): ... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : P... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is di... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testos... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.2... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispens... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN ... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder
Mar 10, 2015 Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding... Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin. Class II Freedom Pharmaceuticals Inc
Mar 6, 2015 DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) Fuse... Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia... Class II Fusion Pharmaceuticals, LLC
Feb 6, 2015 Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg... Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-mo... Class II Tarmac Products, Inc.
Jan 28, 2015 Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, ... Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed US... Class II Akorn, Inc.
Jan 20, 2015 Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx ... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Jan 20, 2015 Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, Am... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Dec 31, 2014 Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... Class II Valeant Pharmaceuticals North America LLC
Dec 17, 2014 Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Tr... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.