Browse Drug Recalls
6,348 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,348 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 6,348 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 21, 2015 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, pa... | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling pr... | Class II | Nephron Pharmaceuticals Corp. |
| Aug 17, 2015 | Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured b... | Lack of Assurance of Sterility: Failed preservative effectiveness testing. | Class II | Bausch & Lomb, Inc. |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 25%, Phenol 2.5%, QS SWI), 1... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Aug 17, 2015 | Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupi... | Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to... | Class I | Hartley Medical Center Pharmacy, Incorporated |
| Jul 24, 2015 | PROGESTERONE, Pellet, 50mg, Rx only, JD & SN Inc, DBA Moses Lake Professional... | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| Jul 24, 2015 | METHIONINE/CHOLINE/INOSITOL, injectable Solution, 25/50/50 MG/ML, 10 mL syrin... | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy |
| Jul 24, 2015 | PAPAVERINE/PHENTOLAMINE, Injectable Solution, 30MG/1MG/ML, 10 mL syringe, Rx... | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy |
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.