CLASS II Drug recall · Reported 22 Mar 2023 · FDA Enforcement Report

Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical

Breckenridge Pharmaceutical is recalling Clobazam Tablets, 10 mg, CIV, distributed nationwide in the US. The recall was initiated on 2 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025

Quantity recalledN/A

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-0462-2023
FDA event ID: 91786
Recalling firm: Breckenridge Pharmaceutical, Berlin, CT
Classification: Class II
Status: Terminated
Recall initiated: 2 Mar 2023
FDA classified: 10 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Seizure Medication

Timeline

2 Mar 2023	Recall initiated by company
10 Mar 2023	Classified by FDA	+8 days
22 Mar 2023	Published in enforcement report	+12 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: Potential risk of Cross Contamination

Product as listed by the FDA

Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01

Where it was distributed

USA nationwide.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Potential risk of Cross Contamination

Which lots are affected?

Lot # 5210085, Exp 12/2023; 5210248, Exp 01/2024; 5220796, Exp 07/2025

Where was it sold?

USA nationwide.

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

5 other products · FDA event 91786

This product is part of a recall event; the main page for the event is Alprazolam Tablets, USP, 1 mg, CIV recalled.

Reported	Class	Recall	Company	Reason	Where
22 Mar 2023	CLASS II	Alprazolam Tablets, USP, 1 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023	CLASS II	Alprazolam Tablets, USP, 0.25mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023	CLASS II	Alprazolam Tablets, USP, 0.5mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023	CLASS II	Alprazolam Tablets, USP, 2 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023	CLASS II	Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Breckenridge Pharmaceutical

All 35

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide

Other Clobazam recalls

All 7

Reported	Class	Recall	Company	Reason	Where
22 Jan 2025Drug	CLASS II	Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam	Amerisource Health Services	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam	Amerisource Health Services	Packaging Defects	Nationwide
28 Feb 2024Drug	CLASS II	Clobazam Tablets 10mg recalled by Micro LabsClobazam	Micro Labs	Potency & Assay	Nationwide
22 Mar 2023Drug	CLASS II	Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
26 Jan 2022Drug	CLASS II	Clobazam Oral Suspension 2.5 mg/mL recalled by VistaPharm	VistaPharm	Potency & Assay	Nationwide