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Class III · Lower riskRecall completed

Metoprolol

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #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;
Where it was soldDistributed nationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBaxter Healthcare Corporation
Brand nameMETOPROLOL
Generic nameMETOPROLOL TARTRATE
Active ingredient(s)METOPROLOL TARTRATE
Distributed by / forClaris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India
NDC36000-033-10
Show the full FDA record
Full product labelMetoprolol 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
Recalling firmBaxter Healthcare Corporation
DistributionDistributed nationwide in the USA and Puerto Rico
Quantity402,165 vials
Recall initiated2018-10-15
Report date2018-11-14
Recall completed2022-08-12
Recall numberD-0222-2019
ClassificationClass III
FDA statusTerminated
Origin on fileDeerfield IL United States

Related

Metoprolol recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.