Class II · Moderate risk Ongoing
Medline
Reason Subpotent Drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class II · Moderate risk Ongoing
Afco
Reason 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 Ongoing
Wyandotte
Reason 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 Ongoing
Succinylcholine Chloride Injection
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk Ongoing
Aloe Up Sport Performance Sunscreen Lotion SPF 30
Reason cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk Ongoing
Fentanyl citrate
Reason CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk Ongoing
Sting Relief Swabs
Reason Product Mix-up
Class II · Moderate risk Terminated
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Reason Lack of assurance of sterility.
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Atorvastatin Calcium Tablets USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Azelaic Acid Gel
Reason CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk Ongoing
Phenylephrine HCI
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason 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 Ongoing
Carbamazepine Extended-Release Tablets
Reason Failed Dissolution Specifications.
Class II · Moderate risk Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP
Reason Failed Tablet/Capsule Specifications
Class II · Moderate risk Ongoing
edunn clarity
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Micronized BPO Gel Cleanser 10%
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
mel rx Skin
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Class II · Moderate risk Ongoing
Skin MD by Dr Monika Kiripolsky
Reason Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.