The Recall Desk
ModerateFDA (Drugs)·D-0711-2022·Announced 2022-03-30

Phenylephrine HCl Injection Recalled for Defective Container

Athenex Pharma Solutions is recalling Phenylephrine HCl Injection (20 mg, 250 mL excel bags) distributed nationwide due to defective container issues. The recall affects three specific lots.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a defective container (a manufacturing or packaging issue). The source text does not report any illnesses or injuries, and the hazard is a container defect rather than chemical contamination or a high-risk pathogen, meeting the criteria for a Moderate severity rating.

Plain-English summary

Athenex Pharma Solutions, LLC is recalling Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bags, distributed nationwide in the United States. A total of 1,980 bags are affected by this recall.

The recall was initiated because of a defective container. The affected lots are: Lot #F2101654 (expiration 5/30/22), Lot #F2101834 (expiration 7/03/22), and Lot #F2200110 (expiration 7/27/22). The product is prescription-only.

This is a voluntary recall initiated by the firm. The recall was reported on March 30, 2022, and was terminated on August 4, 2022. Healthcare providers and patients who have received this product should contact Athenex Pharma Solutions, LLC or their healthcare provider for guidance.

The recalled product

Product
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15
Manufacturer
Athenex Pharma Solutions, LLC
Category
Drug — Injectable / Vasoconstrictor
Hazard
Affected units
1,980

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #: F2101654
  • Exp 5/30/22
  • F2101834
  • Exp 7/03/22
  • F2200110
  • Exp 7/27/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Athenex Pharma Solutions, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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