Metoprolol Tartrate Injection (Baxter) – pH Specification Failure (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Lot #S: A061267, A061273, EXP 10/2018, A061392, A061395, A061398, A061403, A061407, EXP 11/2018, A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018, A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019, A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019, A0A0361, A0A0367, A0A0390, EXP 3/2019, A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019, A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019, A0A0777, EXP 7/2019, A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019, A0A1094, A0A1097, A0A1110, EXP 11/2019
Products Sold
Lot #S: A061267, A061273,EXP 10/2018; A061392, A061395, A061398, A061403, A061407, EXP 11/2018; A0A0070, A0A0073, A0A0079, A0A0081, A0A0083, EXP 12/2018; A0A0119, A0A0124, A0A0125, A0A0133, A0A0141, A0A0145, A0A0152, EXP 1/2019; A0A0247, A0A0252, A0A0253, A0A0292, A0A0293, EXP 2/2019; A0A0361, A0A0367, A0A0390, EXP 3/2019; A0A0438, A0A0445, A0A0453, A0A0459, EXP 4/2019; A0A0547, A0A0551, A0A0554, A0A0630, A0A0631, A0A0637, A0A0638, EXP 5/2019; A0A0777, EXP 7/2019; A0A0915, A0A0919, A0A0924, A0A0930, EXP 8/2019; A0A1094, A0A1097, A0A1110, EXP 11/2019;
Baxter Healthcare Corporation is recalling Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx due to Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026