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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 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 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 |
| Aug 31, 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe... | Falied pH specification | Class III | Oasis Medical, Inc. |
| Aug 28, 2015 | LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Ch... | Subpotent Drug: trace amounts of methylcobalamin in compounded drug. | Class II | Eagle Pharmacy, Inc. |
| Aug 27, 2015 | MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules ... | Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosilden... | Class I | The One Minute Miracle Inc |
| Aug 27, 2015 | MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The ... | Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphth... | Class I | The One Minute Miracle Inc |
| Aug 25, 2015 | Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-... | Lack of Assurance of Sterility: Failed preservative effectiveness testing | Class II | Apotex Inc. |
| Aug 25, 2015 | 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservati... | Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded i... | Class II | Hospira, Inc. |
| Aug 24, 2015 | Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containe... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | TruTrim (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Xcellerator (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Oin... | Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... | Class II | Allergan Sales, LLC |
| Aug 24, 2015 | The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Sup... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
| Aug 24, 2015 | BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... | Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... | Class II | Allergan Sales, LLC |
| Aug 24, 2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distribu... | Labeling: Wrong Bar Code | Class II | C. O. Truxton |
| Aug 24, 2015 | FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan... | Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... | Class II | Allergan Sales, LLC |
| Aug 24, 2015 | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant E... | Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... | Class II | Allergan Sales, LLC |
| Aug 24, 2015 | MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule ... | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in ... | Class I | Novacare, LLC |
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.