Class I · High risk
Morphine Sulfate PF 25 mg/25mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class I · High risk
HYDROmorphone HCl PF 10 mg/50 mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk
Premium Nature Instant Hand Sanitizer
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class I · High risk
Hard Dawn
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
Class I · High risk
Polymyxin B for Injection USP
Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
Class II · Moderate risk
Cystex Tablet
CGMP Deviations
Class II · Moderate risk
DBI Magnums Tablet
CGMP Deviations
Class II · Moderate risk
Coated Back Relief Tablet
CGMP Deviations
Class II · Moderate risk
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
CGMP Deviations
Class II · Moderate risk
Back Relief II
CGMP Deviations
Class II · Moderate risk
Pain Aid PMF Caplet
CGMP Deviations
Class II · Moderate risk
Normed Fem Tablet
CGMP Deviations
Class II · Moderate risk
APAP 325 mg
CGMP Deviations
Class II · Moderate risk
Migrenol Caplet
CGMP Deviations
Class II · Moderate risk
Coated Phenylephrine HCl 5mg Tablet
CGMP Deviations
Class II · Moderate risk
Phenylephrine HCl 5 mg Tablet
CGMP Deviations
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Nutralox Peppermint Antacid
CGMP Deviations
Class II · Moderate risk
Spearmint Antacid Tablet
CGMP Deviations
Class II · Moderate risk
Trial Antacid Tablet
CGMP Deviations
Class II · Moderate risk
Cherry Antacid Tablet
CGMP Deviations
Class II · Moderate risk
Peppermint Antacid tablet
CGMP Deviations
Class II · Moderate risk
HPC Tablet
CGMP Deviations
Class II · Moderate risk
APAP 500 mg SRC Coated
CGMP Deviations