Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,293 recalls, newest first

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

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0441-05 D-1228-2014
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

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0440-05 D-1227-2014
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.

Terminated Labeling / mix-up Medisca Inc D-0674-2016
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%.

Terminated Labeling / mix-up Fougera Pharmaceuticals Inc. NDC 0168-0004-80 D-1152-2014
Class II · Moderate risk

Trelstar (triptorelin pamoate)

Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.

Terminated Labeling / mix-up Actavis Inc NDC 52544-154-02 D-1085-2014
Class II · Moderate risk

0.45% Sodium Chloride Injection USP

Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).

Terminated Labeling / mix-up B. Braun Medical Inc NDC 0264-7802-00 D-407-2014
Class III · Low risk

Paclitaxel Injection

Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Terminated Labeling / mix-up Fresenius Kabi USA, LLC NDC 63323-763-50 D-016-2014
Class II · Moderate risk

Carbon Dioxide

Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.

Terminated Labeling / mix-up Airgas Medical Services D-366-2014
Class II · Moderate risk

sertraline HCl tablets

Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life

Terminated Labeling / mix-up Greenstone LLC NDC 59762-4960-1 D-746-2014
Class II · Moderate risk

Nifedipine

Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.

Terminated Labeling / mix-up Greenstone Llc NDC 59762-6692-8 D-737-2014
Class I · High risk

Human Chorionic Gonadotropin

Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Terminated Labeling / mix-up Medisca Inc. NDC 38779-2673-1 D-1263-2014
Class III · Low risk

Potassium Chloride

Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.

Terminated Labeling / mix-up Cardinal Health D-0489-2015
Class III · Low risk

Acanya (Clindamycin Phosphate and Benzoyl Peroxide)

Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an incorrect expiration date assigned to a lot of physicians samples.

Terminated Labeling / mix-up Valeant Pharmaceuticals North Am NDC 13548-132-03 D-020-2014
Class II · Moderate risk

Ibu (NDC 55111-684-05)

Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Terminated Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 55111-684-05 D-1042-2013
Class II · Moderate risk

K Effervescent Tablets

LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 count K Effervescent Tablets.

Terminated Labeling / mix-up Qualitest Pharmaceuticals D-1036-2013
Class III · Low risk

Introvale (levonorgestrel and ethinyl estradiol)

Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card

Terminated Labeling / mix-up Sandoz Incorporated NDC 0781-5584-36 D-854-2013
Class III · Low risk

Maalox

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Terminated Labeling / mix-up Novartis Consumer Health D-907-2013
Class III · Low risk

Maalox Extra Strength Antacid

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Terminated Labeling / mix-up Novartis Consumer Health D-906-2013
Class III · Low risk

Maalox Regular Strength Antacid

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

Terminated Labeling / mix-up Novartis Consumer Health D-903-2013

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