Class II · Moderate risk
Celecoxib Capsules
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
Esomeprazole Magnesium for Delayed-Release Oral Suspension
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
Esomeprazole Magnesium for Delayed-Release Oral Suspension
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
Chlorthalidone Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Celecoxib Capsules
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
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Failed Impurities/Degradation Specifications
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
Polyvinyl Alcohol Ophthalmic Solution 1.4%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Lubricant Eye Drops Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Artificial Tears Ophthalmic Solution
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Clindamycin HCl Capsule
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II · Moderate risk
BENLYSTA (belimumab)
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays