Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III drug recalls - low risk

Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.

1,716 recalls, 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

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
Class III · Low risk

Midol Complete

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Terminated Labeling / mix-up Bayer Healthcare, LLC NDC 0280-8005-16 D-1424-2012
Class III · Low risk

Midol Complete

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

Terminated Labeling / mix-up Bayer Healthcare, LLC NDC 0280-8015-24 D-1423-2012
Class III · Low risk

CABERGOLINE Tablets

Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

Terminated Impurity / degradation Teva Pharmaceuticals USA, Inc. NDC 0093-5420-88 D-128-2013
Class III · Low risk

Loxitane Capsules

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Terminated Labeling / mix-up Watson Laboratories Inc NDC 52544-495-01 D-1403-2012
Class III · Low risk

Loxapine Capsules USP

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Terminated Labeling / mix-up Watson Laboratories Inc NDC 0591-0372-01 D-1402-2012
Class III · Low risk

Loxapine Capsules USP

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Terminated Labeling / mix-up Watson Laboratories Inc NDC 0591-0371-01 D-1401-2012
Class III · Low risk

Loxapine Capsules USP

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Terminated Labeling / mix-up Watson Laboratories Inc NDC 0591-0370-01 D-1400-2012

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