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

1,525 recalls · Class III, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class III · Low risk

Tizanidine

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Terminated Labeling / mix-up Stat Rx USA NDC 16590-221-90 D-1427-2012
Class III · Low risk

Fougera Ketoconazole Cream 2%

Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product

Terminated Impurity / degradation Fougera Pharmaceuticals Inc. NDC 0168-0099-15 D-241-2013
Class III · Low risk

Major brand Infants' Mapap

Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

Terminated Stability / shelf life Axcentria Pharmaceuticals LLC NDC 0904-5255-30 D-1441-2012
Class III · Low risk

Hydroxyzine Hydrochloride Oral Solution

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

Terminated Impurity / degradation Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals NDC 0603-1310-58 D-1417-2012
Class III · Low risk

Carboplatin Injection

Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

Terminated Failed specification Hospira Inc. NDC 61703-339-18 D-1648-2012
Class III · Low risk

Nexium (esomeprazole magnesium)

Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.

Terminated Particulate / foreign matter ASTRA ZENECA Lp NDC 0186-5040-85 D-1410-2012
Class III · Low risk

Famotidine Tablets USP

Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.

Terminated Impurity / degradation Mylan Pharmaceuticals Inc. NDC 0378-3020-01 D-1703-2012
Class III · Low risk

Super Colon Cleanse

Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.

Terminated Labeling / mix-up Health Plus Incorporated D-1406-2012
Class III · Low risk

Tobramycin Ophthalmic Oint.

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Terminated Labeling / mix-up Stat Rx USA NDC 16590-224-05 D-050-2013
Class III · Low risk

Erythromycin Topical Solution USP

Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.

Terminated Chemical / undeclared Fougera Pharmaceuticals, Inc. NDC 0168-0215-60 D-1426-2012
Class III · Low risk

Pitocin (Oxytocin Injection, USP)

Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".

Terminated Labeling / mix-up JHP Pharmaceuticals, LLC NDC 42023-116-02 D-1420-2012
Class III · Low risk

Leukine sargramostim 5 x 500 mcg/mL vial

Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.

Terminated Impurity / degradation Bayer HealthCare Pharmaceuticals Inc. NDC 58468-0181-2 D-156-2013
Class III · Low risk

Morton

Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.

Terminated Impurity / degradation Morton Salt Co. D-1656-2012
Class III · Low risk

Endocet (oxycodone and acetaminophen)

Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.

Terminated Particulate / foreign matter Endo Pharmaceuticals, Inc. NDC 60951-797-70 D-1381-2012

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