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Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Complete recall history across all FDA and CPSC categories — 39 total recalls

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (39)

FDA drug safety enforcement actions by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Date Product Reason Class
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II
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 preparati... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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