Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

18,003 recalls, newest first

Class I · High risk

0.9% Sodium Chloride Injection

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0049-31 D-1163-2014
Class I · High risk

5% Dextrose Injection

Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0017-38 D-1162-2014
Class I · High risk

vitaliKOR Ready When You Are

Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules

Terminated Chemical / undeclared Vitality Research Labs LLC D-1364-2014
Class I · High risk

RezzRX capsules

Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Terminated Chemical / undeclared Fossil Fuel Products, LLC D-1248-2014
Class I · High risk

eXtenZone capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b

Terminated Chemical / undeclared SS Wholesale Inc. dba Jobbers Wholesale D-1047-2014
Class I · High risk

MaXtremeZEN capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved

Terminated Chemical / undeclared SS Wholesale Inc. dba Jobbers Wholesale D-1046-2014
Class I · High risk

Rhino 5 capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by

Terminated Chemical / undeclared SS Wholesale Inc. dba Jobbers Wholesale D-1045-2014
Class III · Low risk

Ketoconazole Cream

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

Terminated Impurity / degradation Fougera Pharmaceuticals Inc. NDC 0168-0099-30 D-1044-2014
Class II · Moderate risk

Phenylephrine Nasal 1% Spray

Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.

Terminated Microbial contamination Tower Pharmacy and Compounding D-384-2014
Class I · High risk

Glycopyrrolate

Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Terminated Sterility / contamination Brookfield Prescription Center Inc D-1252-2014
Class III · Low risk

Namenda XR

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Terminated Dissolution failure Forest Pharmaceuticals Inc NDC 0456-3428-05 D-1065-2014
Class III · Low risk

Namenda XR

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Terminated Dissolution failure Forest Pharmaceuticals Inc NDC 0456-3400-29 D-1064-2014
Class III · Low risk

Namenda XR

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Terminated Dissolution failure Forest Pharmaceuticals Inc NDC 0456-3407-33 D-1063-2014
Class II · Moderate risk

10%, Travasol

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

Terminated Sterility / contamination Baxter Healthcare Corp. D-368-2014
Class III · Low risk

Paclitaxel Injection

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Terminated Labeling / mix-up Fresenius Kabi USA, LLC NDC 63323-763-50 D-016-2014
Class II · Moderate risk

Carisoprodol Tablets

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing

Terminated Particulate / foreign matter West-Ward Pharmaceutical Corp. NDC 0143-9749-10 D-367-2014

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