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

2,357 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-487-52 D-0554-2023
Class II · Moderate risk

Tadalafil Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-473-87 D-0553-2023
Class II · Moderate risk

Doxazosin Tablets

CGMP Deviations

Ongoing cGMP deviation Northwind Pharmaceuticals LLC NDC 51655-109-52 D-0550-2023
Class II · Moderate risk

Dabigatran Etexilate Capsules

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ongoing Nitrosamine impurity Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023
Class II · Moderate risk

NaturalCare

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Ongoing Failed specification Nutraceutical Corporation D-0440-2023
Class II · Moderate risk

NaturalCare bioAllers

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Ongoing Failed specification Nutraceutical Corporation D-0439-2023
Class II · Moderate risk

NatraBio

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Ongoing Failed specification Nutraceutical Corporation D-0438-2023
Class II · Moderate risk

NaturalCare bioAllers

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Ongoing Failed specification Nutraceutical Corporation D-0437-2023
Class II · Moderate risk

Fentanyl 500mcg

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Ongoing Sterility / contamination Apollo Care NDC 71170-950-25 D-0487-2023
Class II · Moderate risk

Tacrolimus Capsules

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Ongoing Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 55111-525-01 D-0330-2023
Class II · Moderate risk

Delsam Pharma's ARTIFICIAL TEARS

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Ongoing cGMP deviation Global Pharma Healthcare Private Limited D-0922-2023
Class II · Moderate risk

Artificial Tears

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

Ongoing cGMP deviation Global Pharma Healthcare Private Limited NDC 79503-0101-15 D-0920-2023
Class II · Moderate risk

Hand Sanitizer

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Ongoing cGMP deviation Fisher Scientific Co., LLC D-0164-2023

Recalls by year