Class II · Moderate risk
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
rocuronium Bromide
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
succinylcholine Chloride
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
fentaNYL Citrate 10 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
HYDROmorphone in 0.9% Sodium Chloride HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
rocuronium Bromide 10 mg per mL 50 mg per 5 mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
nICARdipine HCl
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class II · Moderate risk
ePHEDrine Sulfate
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Class I · High risk
Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary…
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Class II · Moderate risk
Gentamicin 80mg/60 mL Irrigation
Lack of Assurance of Sterility
Class II · Moderate risk
Advil Liqui-Gel Mini 160+20+20 CT
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
*Mitomycin 0.04% Ophth DR eye drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
*Morphine 2 mg/mL Cassette
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Vancomycin Opthal 14 mg drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
C-*Albumin Eye Drop 10% S
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.