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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 4,201–4,220 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310

by Teligent Pharma, Inc.

Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Recall initiated
March 15, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in the USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

by Blaine Labs Inc

Reason
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Recall initiated
January 25, 2022
Reported by FDA
March 30, 2022
Distribution
Nationwide in 17 States to 45 doctors.

View recall →

Drug Recall Terminated Historical recordClass I

Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.

by Walmart Stores

Reason
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
February 9, 2022
Reported by FDA
March 23, 2022
Distribution
Nationwide in the USA via www.walmart.com

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

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.