Metoprolol Tartrate Injection

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.

What was recalled

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

Affected NDC 36000-0033-10

Compare with the code on your package — it is the most precise check available.

Drug: Metoprolol Category: Blood Pressure Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Metoprolol metoprolol tartrate NDC 36000-0033	5 mg/5mL	Injection Intravenous	Baxter Healthcare Corporation	Rx

Recalling firm: Baxter Healthcare Corporation
Origin: IL, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0222-2019 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.