Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 4,101–4,120 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass I

Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.

by Pink Toyz

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found the product 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
March 29, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide in the USA via walmart.com online marketplace

View recall →

Drug Recall Terminated Historical recordClass II

artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5

by VIRGIN SCENT INC

Reason
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Recall initiated
October 26, 2021
Reported by FDA
April 27, 2022
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

View recall →

Drug Recall Terminated Historical recordClass II

Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60

by MYLAN PHARMACEUTICALS INC

Reason
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Recall initiated
April 7, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Recall initiated
March 24, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within the USA.

View recall →

Drug Recall Ongoing Historical recordNot Yet Classified

Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA

by Safecor Health, LLC

Reason
Cross Contamination with Other Products
Recall initiated
April 4, 2022
Reported by FDA
April 20, 2022
Distribution
MA only

View recall →

Drug Recall Terminated Historical recordClass II

Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recall initiated
March 24, 2022
Reported by FDA
April 20, 2022
Distribution
Product distributed in California and Florida.

View recall →

Drug Recall Terminated Historical recordClass II

Preferred Pharmaceuticals, Inc. The Physician's Solution., Lansoprazole Delayed-Release Capsules, 15mg, Generic for Prevacid, 90-Count Bottle, Manufacturer: Dr Reddy's Laboratories Limited, NDC 68788-6390-09

by Preferred Pharmaceuticals, Inc.

Reason
Out of specification results observed in dissolution during long term stability testing.
Recall initiated
March 28, 2022
Reported by FDA
April 20, 2022
Distribution
Nationwide in the USA and CA.

View recall →

Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
Recall initiated
March 23, 2022
Reported by FDA
April 20, 2022
Distribution
IL

View recall →

Drug Recall Terminated Historical recordClass III

Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

by Aurobindo Pharma USA Inc.

Reason
Subpotent Drug: Out of Specification results for Assay
Recall initiated
April 5, 2022
Reported by FDA
April 20, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

by Teva Pharmaceuticals USA Inc

Reason
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Recall initiated
March 29, 2022
Reported by FDA
April 20, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Recall initiated
April 1, 2022
Reported by FDA
April 13, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.

by Adamis Pharmaceuticals Corporation

Reason
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Recall initiated
March 21, 2022
Reported by FDA
April 13, 2022
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Terminated Historical recordClass I

SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02

by Adamis Pharmaceuticals Corporation

Reason
Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Recall initiated
March 21, 2022
Reported by FDA
April 13, 2022
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Terminated Historical recordClass III

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

by Macleods Pharma Usa Inc

Reason
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Recall initiated
March 10, 2022
Reported by FDA
April 13, 2022
Distribution
USA 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.