Class II · Moderate risk
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes…
Lack of sterility assurance.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL…
Lack of sterility assurance.
Class II · Moderate risk
Magnesium Sulfate 200 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL…
Lack of sterility assurance.
Class II · Moderate risk
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials…
Lack of sterility assurance.
Class II · Moderate risk
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes…
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV…
Lack of sterility assurance.
Class II · Moderate risk
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled…
Lack of sterility assurance.
Class II · Moderate risk
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml…
Lack of sterility assurance.
Class II · Moderate risk
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100…
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD…
Lack of sterility assurance.
Class I · High risk
7K capsules packaged in single packs sold in 24-count boxes
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class I · High risk
POSEIDON Xtreme PLATINUM 4500
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Class II · Moderate risk
My Way (levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk
My Way (Levonorgestrel)
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Class II · Moderate risk
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Class II · Moderate risk
screamin' menthol
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk
screamin' hot
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class II · Moderate risk
Silver-Zinc Throat Spray
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk
Argentum Elixir Colloidal Silver
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk
Expectorant Cough Syrup
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk
Stomach Calm
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk
Intestinal Colic Drops
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Class II · Moderate risk
Nausea Drops
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.