Class III · Low risk
Acetaminophen 500 mg tablet
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
FDA Drug Recalls
1,018 recalls, newest first
Class III · Low risk
Acetaminophen 325 mg tablets
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class III · Low risk
Zynrelef (bupivacaine and meloxicam)
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class I · High risk
Banana Boat hair & scalp defense
Chemical contamination: presence of benzene
Class II · Moderate risk
Rifampin Capsules
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
Divalproex Sodium Extended Release Tablets
Failed dissolution specifications.
Class III · Low risk
Azacitidine for Injection
Subpotent Drug
Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class I · High risk
SANGTER Energy Supplement Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I · High risk
SUSTANGO (Pendenadril Tytrate Blend)
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.
Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Prednisone Tablets USP
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations