Browse Drug Recalls

1,317 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,317 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 1,317 FDA drug recalls in IL.

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DateProductReasonClassFirm
Mar 24, 2015 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxte... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactu... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 23, 2015 Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 23, 2015 Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 18, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 18, 2015 CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Mul... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, 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 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 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 (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) 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 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) : 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 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 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 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 (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) : 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 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) 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 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 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 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)): ... 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 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 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 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 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) : 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 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 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) 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 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 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 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 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 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 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 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 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

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.