Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Failed Impurities/Degradation Specifications
Class I · High risk
Endurance Boost With Horny Goat Weed
Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
TESTOSTERONE PELLET 200 mg BLUNT
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk
TESTOSTERONE PELLET 200 mg
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk
TESTOSTERONE PELLET 200 mg BLUNT
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk
TESTOSTERONE PELLET 200 mg
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk
TESTOSTERONE PELLET 100 mg
Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk
temper tamer
CGMP Deviations
Class II · Moderate risk
Infuvite Adult
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security Anticavity Gel Toothpaste
CGMP Deviations
Class II · Moderate risk
Cinnafresh anticavity gel toothpaste
CGMP Deviations
Class II · Moderate risk
Rapidol
CGMP Deviations
Class II · Moderate risk
Rapidol Maximum Strength
CGMP Deviations