Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 12, 2015 | Hyaluronic Acid/Lidocaine (20 mg/1%/2 mL), 3 mL Single Use Syringe, For Intra... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Triamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Inje... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic us... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Choline chloride 50 mg/mL, Inositol 50 mg/mL Cyanocobalamin 1000 mcg/mL, 30 m... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL),... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Hyaluronic Acid/Lidocaine PF (20 mg/1%), 2 mL Single-Use Syringe , For Intra-... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Hyaluronidase PF (150 units/mL) in 1 mL Single-Use Vial, Not for IV Use, Rx o... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Zinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, R... | 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 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Op... | 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 EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM In... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Region... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection,... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx ... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-A... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles; For topical op... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Tropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL U... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| Sep 12, 2015 | Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Inje... | Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within ex... | Class II | US Compounding Inc |
| 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... |
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.