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Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 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 1,733 FDA drug recalls in 2015.

Clear
DateProductReasonClassFirm
Mar 17, 2015 Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Welln... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 17, 2015 Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection, Fallon W... Lack of assurance of sterility Class II Fallon Wellness Pharmacy, L.L.C.
Mar 12, 2015 Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-0... Failed Tablet/Capsule Specifications: out of specification for thickness. Class II Wockhardt Usa Inc.
Mar 11, 2015 Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outd... Failed Impurities/Degradation Specifications: out of specification results for a related compound... Class III Mylan Pharmaceuticals Inc.
Mar 11, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the soluti... Class I Hospira Inc.
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 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : 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 AIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen... Failed Impurities/Degradation Specification; out of specification results for carbon dioxide Class III Matheson, Inc.
Mar 10, 2015 TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / 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 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) ... 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 BIEST TD 89/11 (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 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)) 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) 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 Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by... Failed Impurities/Degradation Specifications: during long-term stability testing. Class II Mutual Pharmaceutical Company, Inc.
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 ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semil... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains u... Class I Ultra ZX Supplements
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

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.