Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP)
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
FDA Drug Recalls
1,293 recalls, newest first
Class III · Low risk
Loxitane Capsules
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Loxapine Capsules USP
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Class III · Low risk
Ciprofloxacin Tablets
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Class II · Moderate risk
Prefera OB One Gel Capsules
Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.
Class II · Moderate risk
Docusate Calcium Softgel Capsules
Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Class I · High risk
metFORMIN ER Tablets
Labeling: Label Mix up; product labeled did not indicated Extended Release
Class I · High risk
Oxycodone HCl Oral Concentrate
Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL
Class I · High risk
Taztia XT (Diltiazem HCl)
Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules
Class III · Low risk
Metoclopramide Oral Solution
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
Class I · High risk
Morphine Sulfate Immediate Release tablet
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Class I · High risk
Morphine Sulfate Extended Release tablet
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
Class II · Moderate risk
Eye Drops advanced relief
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.