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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 12,721–12,740 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013

by Qualgen

Reason
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Recall initiated
October 9, 2015
Reported by FDA
December 2, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Reason
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall initiated
September 3, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.