A drug recall occurs when a medication is removed from the market because it is found to be either defective or potentially harmful. The FDA along with pharmaceutical companies monitors medications out on the market for unforeseen problems. If an issue is identified, or the safety of the medication becomes a concern, a recall is initiated.

Information provided below are important new safety information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care providers about the best course of action.

• Class I Recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class II Recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III Recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
• Market Withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.

The hyperlinks below contain important new safety information regarding drug recalls. If you are taking a medication that has been recalled, please talk to your health care provider about the best course of action.

1. Enforcement Reports | FDA
2. Recalls, Market Withdrawals, & Safety Alerts | FDA
3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA
4. Recalls (Biologics) | FDA

Class I - November 29, 2023

• Sodium Bicarbonate Injection 8.4% 50 mEq/50 mL (1mEq/mL) 
• Midazolam in 0.8% Sodium Chloride Injection 100mg/100 mL
• ELCYS (Cysteine Hydrochloride Injection) 500 mg/10 mL 

Class I – November 22, 2023

• Oxygen, Compressed (Recalling Firm: Family Medical Supply Inc.) 

Class I Recall - November 18, 2023

• KinderMed Infants' Pain & Fever (Acetaminophen - 160 mg per 5mL)
• KinderMed Kids' Pain & Fever (Acetaminophen - 160 mg per 5mL)

Class I Recall - November 15, 2023

• Sodium Bicarbonate Injection 4.2% 5 mEq/10 mL
• Lidocaine HCL Injection 1% 50 mg/5 mL
• Lidocaine HCL Injection 2% 100 mg/ 5 mL

Class I Recall – November 1, 2023

• ION Sinus Spray 1 fl. oz 
• Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6% and Tetrahydrozoline Hydrocholoride 0.05%) 0.5 fl. oz bottle (15 mL) 
• Dry Eye Relief (Carboxymethylcellulose Sodium 1%) 0.5 fl. oz bottle (15 mL) 
• Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) 0.5 fl. oz bottle (15 mL)
• Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) 2 bottles 0.5 fl. oz (15 mL) each
• Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol 0.3%) 0.33 fl. oz bottle (10 mL) 
• Lubricant Eye Drops (Propylene Glycol 0.6%) 0.33 fl. oz bottle (10 mL) 
• Polyvinyl Alcohol 1.4% Lubricating Eye Drops 0.5 oz bottle (15 mL) 
• Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) 0.5 oz bottle (15 mL)

• Past drug recalls, alerts and market withdrawals