Class III · Low risk
Mercaptopurine Tablets USP
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
FDA Drug Recalls
36 recalls, newest first
Class III · Low risk
Azathioprine Tablets USP
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Class III · Low risk
Psyllium Fiber
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Class III · Low risk
Demerol
Labeling; Missing label; ampoules are missing the immediate container label
Class III · Low risk
Polidocanol 1% Solution
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class III · Low risk
Papaverine 60 mg
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class II · Moderate risk
Phosphatidylcholine Solution for Injection
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
Class III · Low risk
Ritalin HCl
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Class III · Low risk
Ritalin HCl
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Class I · High risk
Citrulline
Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.