The Recall Desk
CriticalFDA (Drugs)·D-0627-2021·Announced 2021-06-09

Pfizer Lidocaine and Bupivacaine Injection Label Mix-Up Recall

Pfizer has recalled 139,050 vials of injectable anesthetic medications due to a label mix-up: some vials labeled as Lidocaine contain Bupivacaine, and some labeled as Bupivacaine contain Lidocaine. Patients and healthcare providers should verify medication identity before use.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I. Per the severity rubric, FDA Class I recalls are classified as Critical (score 5), the highest severity level, because they involve a situation in which use of the recalled product will cause serious adverse health consequences or death.

Plain-English summary

Pfizer, Inc. is recalling 139,050 vials of injectable anesthetic products due to a critical labeling error. Some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may actually contain 1% Lidocaine HCl Injection, USP. Conversely, some vials labeled to contain 1% Lidocaine HCl Injection, USP may actually contain 0.5% Bupivacaine Hydrochloride Injection, USP.

The affected product is 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL) in 30 mL single-dose vials (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02). Lot EG8933 with expiration 08/01/2022 is involved. The product was distributed nationwide in the USA, Puerto Rico, and Guam by Hospira, Inc. (Lake Forest, IL), a Pfizer subsidiary.

Administration of the wrong anesthetic drug or the wrong concentration could result in inadequate anesthesia, overdose, or other serious adverse effects. Healthcare providers and patients who have received or have in possession vials from this lot should verify the actual medication identity before use and contact their healthcare provider or Pfizer with any questions about medication received.

The recalled product

Product
LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Brand
LIDOCAINE HYDROCHLORIDE
Manufacturer
PFIZER, INC
Category
Drug — Injectable Anesthetic
Hazard
Affected units
139,050

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 (2)

  • Lot EG8933
  • Exp. 08/01/2022

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by PFIZER, INC 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 2 products in this recall →

Related recalls

Same brand · LIDOCAINE HYDROCHLORIDE

Same manufacturer · PFIZER, INC

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Same hazard · label mix up

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