CLASS II ONGOING Drug recall · Reported 20 Aug 2025 · FDA Enforcement Report

Metoprolol Tartrate Tablets, USP, 50 mg recalled

Westminster Pharmaceuticals is recalling Metoprolol Tartrate Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26

Quantity recalled16,672 1000-count bottles

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-0581-2025
FDA event ID: 97395
Recalling firm: Westminster Pharmaceuticals, Nashville, TN
Classification: Class II
Status: Ongoing
Recall initiated: 6 Aug 2025
FDA classified: 12 Aug 2025
Reported: 20 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

6 Aug 2025	Recall initiated by company
12 Aug 2025	Classified by FDA	+6 days
20 Aug 2025	Published in enforcement report	+8 days

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

Reason for recall

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Which lots are affected?

Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26

Where was it sold?

Nationwide in the USA.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

Other products in this recall event

1 other product · FDA event 97395

This product is part of a recall event; the main page for the event is Metoprolol Tartrate Tablets, USP, 100 mg recalled.

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025	CLASS II	Metoprolol Tartrate Tablets, USP, 100 mg recalled	Westminster Pharmaceuticals	Nitrosamine Impurity	Nationwide

More recalls from Westminster Pharmaceuticals

All 10

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Metoprolol Tartrate Tablets, USP, 100 mg recalled	Westminster Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Westminster Irbesartan Tablets, USP 150 mg recalled	Westminster Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Westminster Irbesartan Tablets, USP 300 mg recalled	Westminster Pharmaceuticals	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Westminster Irbesartan Tablets, USP 75 mg recalled	Westminster Pharmaceuticals	Nitrosamine Impurity	Nationwide
29 Aug 2018Drug	CLASS I	Levothyroxine and Liothyronine (Thyroid Tablets, USP) recalled	Westminster Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Other Metoprolol recalls

All 40

Reported	Class	Recall	Company	Reason	Where
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