Class II · Moderate risk
Hydroxo-B12 *1ml* Sdv 1mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Class II · Moderate risk
Hcg *10ml* Mdv 500u/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Folinic Acid Mdv Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Folinic Acid Mdv
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Folic Acid 1ml Sdv 10mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Ferr Gluc/Procaine 10ml Mdv 60/10mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Dmso 6.25% Ophth.
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Dmps Acid *5ml* Sdv 50mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Co-Q-10 Oil 20ml Mdv
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate 0.5% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Atropine Sulfate 0.01% Ophth
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
5-Mthf Sdv 5mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
5-Mthf 10ml Sdv
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
5-Mthf 10ml Mdv
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
5-Mthf *10ml* Mdv 5mg/Ml Inj
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk
Riomet (metformin hydrochloride)
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Estrone USP
cGMP Deviations; lack of quality assurance.
Class III · Low risk
Zinc Oxide Paste 25%
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Class III · Low risk
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class II · Moderate risk
EEMT (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk
EEMT HS (esterified estrogens and methyltestosterone)
CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk
Levonorgestrel
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class II · Moderate risk
Estradiol (17-B-Estradiol; Estra-1,3,5(10)
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class I · High risk
Hyland's Baby Nighttime Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Class I · High risk
Hyland's Baby Teething Tablets
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.