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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 2,761–2,780 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass I

Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.

by Gadget Island, Inc

Reason
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Recall initiated
April 26, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.

by Family Dollar Stores, Llc.

Reason
CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated
March 31, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

by Family Dollar Stores, Llc.

Reason
CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated
March 31, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

by Family Dollar Stores, Llc.

Reason
CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated
March 31, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.

by Family Dollar Stores, Llc.

Reason
CGMP deviation: product outside labeled storage temperature requirements.
Recall initiated
March 31, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.

by Seatex LLC

Reason
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Recall initiated
April 19, 2023
Reported by FDA
May 10, 2023
Distribution
FL, GA, TX

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Drug Recall Terminated Historical recordClass II

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
April 6, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
April 6, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
April 6, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
April 6, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
April 6, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the US.

View recall →

Drug Recall Ongoing Historical recordClass III

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Recall initiated
April 20, 2023
Reported by FDA
May 10, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

by Sun Pharmaceutical Industries Ltd.

Reason
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Recall initiated
April 19, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44

by SCA Pharmaceuticals

Reason
Subpotent Drug: Out of specification results for low potency was obtained.
Recall initiated
April 10, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

View recall →

Drug Recall Ongoing Historical recordClass II

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

View recall →

Drug Recall Ongoing Historical recordClass II

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52

by Northwind Pharmaceuticals LLC

Reason
CGMP Deviations
Recall initiated
March 16, 2023
Reported by FDA
May 3, 2023
Distribution
Nationwide with the United States

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.