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Browse Drug Recalls

6,256 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,256 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 6,256 FDA drug recalls.

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DateProductReasonClassFirm
Sep 12, 2015 Omnipaque 300 (600 mg/2 mL), 2 mL Single Use Vial (300 mg/mL), For IV or IT I... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Phenylephrine (1 mg/mL), 5 mL Multi-Dose Vial, For SC, IM, IV or penile injec... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Vitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, ... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Testosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM I... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MIC-Combo, 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compou... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Re... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Dex LA 8 (Dexamethasone acetate (8 mg/mL), 10 mL Multi-Dose Vial, For IM & Re... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Inj... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 12, 2015 Fentanyl PF 50 mL (25 mcg/mL), 10 mL Single Use Syringe, For IV, IM or SC inj... Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... Class II US Compounding Inc
Sep 10, 2015 All Products Intended to be Sterile, mediStat Pharmacy, 110 East Azalea Ave.,... Lack of Assurance of Sterility Class II Medistat RX L.L.C.
Sep 3, 2015 Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Ess... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only,... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. Uni... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only,... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMA... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential We... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials,... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, E... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential We... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essentia... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, E... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PH... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Es... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5m... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, R... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, R... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wel... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wel... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PH... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL a... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 m... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bot... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx on... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY,... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essenti... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Es... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 2, 2015 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Singl... Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surf... Class II Baxter Healthcare Corporation

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.