Class III · Low risk
Rodan & Fields Proactiv Solution
Subpotent Drug: Salicylic acid is subpotent.
FDA Drug Recalls
1,525 recalls · Class III, newest first
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.
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.
Class III · Low risk
CABERGOLINE Tablets
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
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.
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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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
Bracco Diagnostics multihance
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Class III · Low risk
Magnesium Sulfate in Water for Injection
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
DermaZinc Spray
Subpotent (Single Ingredient Drug): The firm is recalling the product because the product is subpotent and does not meet the labeled 0.25% zinc pyrithione level.
Class III · Low risk
Balnetar Therapeutic Tar Bath
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
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 III · Low risk
Azelastine HCl Nasal Solution
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
Class III · Low risk
Percocet 10/325 mg tablets
Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk
Enjuvia (synthetic conjugated estrogens, B)
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Class III · Low risk
Earth Force
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
Class III · Low risk
Plavix 75 mg
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
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,"