FDA Recall D-0620-2025

Exela Pharma Sciences LLC · Lenoir, NC

Class II Ongoing 288 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

Lot / code: Lot # 10004077, Exp. 02/28/2026

Quantity: N/A

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Recall record

Recall number: D-0620-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide in the USA
Recall initiated: 2025-07-30
Classified by FDA Center: 2025-09-05
FDA published: 2025-09-17
Recalling firm: Exela Pharma Sciences LLC
Firm location: Lenoir, NC

Drug identification

Brand name(s): SODIUM BICARBONATE
Generic name(s): SODIUM BICARBONATE
Manufacturer(s): Exela Pharma Sciences, LLC
NDC(s): 51754-5001, 51754-5011, 51754-5002, 51754-5012
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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