CLASS III Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report

Metoprolol Tartrate Injection, USP, 5 mg recalled by Baxter Healthcare

Baxter Healthcare is recalling Metoprolol Tartrate Injection, USP, 5 mg/ (1 mg/mL) per sterile single use glass vial, distributed nationwide in the US. The recall was initiated on 15 Oct 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #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;

NDC36000-033

UPC0336000033107

Quantity recalled402,165 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0222-2019
FDA event ID: 81353
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Metoprolol
Manufacturer: Baxter Healthcare Corporation
Classification: Class III
Status: Terminated
Recall initiated: 15 Oct 2018
FDA classified: 7 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Drug class: Blood Pressure Medication

Timeline

15 Oct 2018	Recall initiated by company
7 Nov 2018	Classified by FDA	+23 days
14 Nov 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Distributed nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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;

Where was it sold?

Distributed nationwide in the USA and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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20 May 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalledMetoprolol Succinate	Ascend Laboratories	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide