Injectable Labetalol Hydrochloride Recalled Due to Incomplete Crimp Seals
Pfizer recalls 220,400 cartridges of Labetalol Hydrochloride injection due to potential incomplete crimp seals that could compromise sterility. Affected lots should not be used; healthcare providers should contact Pfizer for guidance.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable medication with incomplete crimp seals that could compromise sterility. No illnesses or injuries have been reported, but the potential for infection from non-sterile injectable product represents a risk-of-harm scenario that justifies a High severity rating.
Plain-English summary
Pfizer Inc. is recalling Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL) supplied in 4 mL single-dose Carpuject cartridges. The recall was initiated because some cartridges may have incomplete crimp seals, which could compromise the sterility assurance of the product.
Labetalol Hydrochloride is an intravenous medication used to manage blood pressure. When administered intravenously, the product must be sterile to prevent infection. Incomplete crimp seals could allow microbial contamination, posing a risk to patient safety.
The recall affects 220,400 cartridges distributed nationwide in the United States and Puerto Rico. Three lot numbers are affected: HJ7566 (expiration 2025/05), HN8747 (expiration 2025/09), and HN8749 (expiration 2025/09). Healthcare providers and patients who have received or have in stock cartridges from these lots should immediately stop use and contact Pfizer for instructions on return or replacement.
The recalled product
- Product
- LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
- Brand
- LABETALOL HYDROCHLORIDE
- Manufacturer
- Pfizer Inc.
- Affected units
- 220,400
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 (4)
- Lot#: HJ7566
- Exp 2025/05 Lot#: HN8747
- Exp 2025/09 Lot#: HN8749
- Exp 2025/09
Distribution
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.
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