Class II · Moderate risk Ongoing
Airsupra
Reason Defective delivery system
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Celecoxib Capsules
Reason Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class II · Moderate risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk Ongoing
Chlorthalidone Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Celecoxib Capsules
Reason Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class II · Moderate risk Ongoing
Phentermine Hydrochloride Capsules
Reason cGMP deviations
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules USP
Reason cGMP deviations
Class II · Moderate risk Ongoing
Bromfenac Ophthalmic Solution 0.09%
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
Endurance Boost With Horny Goat Weed
Reason Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class II · Moderate risk Ongoing
Testosterone Cypionate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg BLUNT
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg BLUNT
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 100 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
temper tamer
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Infuvite Adult
Reason 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 Ongoing
Medroxyprogesterone Acetate Injectable Suspension
Reason 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 Terminated
Nature Mint
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature Mint Anticavity Fluoride Toothpaste
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature Mint Anticavity Fluoride Toothpaste
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature Mint
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature Mint
Reason CGMP Deviations
Class II · Moderate risk Terminated
Nature Mint
Reason CGMP Deviations