Class II · Moderate risk
Tavaborole Topical solution 5%
Discoloration
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class II · Moderate risk
Testo-100 Ciii
Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Class II · Moderate risk
Zicam" Medicated Fruit Drops Elderberry Flavor
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Presence of Particulate Matter: Particulate matter identified as glass
Class II · Moderate risk
Medline
Subpotent Drug
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk
Afco
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk
Wyandotte
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Aloe Up Sport Performance Sunscreen Lotion SPF 30
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk
Sting Relief Swabs
Product Mix-up
Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class I · High risk
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II · Moderate risk
Carbamazepine Extended-Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications