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

Alprazolam Tablets, USP, 2 mg, CIV recalled

Breckenridge Pharmaceutical is recalling Alprazolam Tablets, USP, 2 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 # 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2023, 500's Bottle 5210642, exp. date 3/31/2023, 100's Bottle 5210643, exp. date 3/31/2023, 100's Bottle 5210644, exp. date 3/31/2023, 500's Bottle 5210766, exp. date 4/30/2023, 100's Bottle 5210767, exp. date 4/30/2023, 100's Bottle 5210768, exp. date 4/30/2023, 500's Bottle 5210999, exp. date 5/31/2023, 500's Bottle 5211000, exp. date 5/31/2023, 500's Bottle 5211001, exp. date 5/31/2023, 500's Bottle 5211002, exp. date 5/31/2023, 500's Bottle 5211003, exp. date 5/31/2023, 500's Bottle 5211004, exp. date 6/30/2023, 500's Bottle 5211005, exp. date 6/30/2023, 500's Bottle 5211006, exp. date 6/30/2023, 500's Bottle 5211055, exp. date 6/30/2023, 500's Bottle 5211332, exp. date 7/31/2024, 500's Bottle 5211333, exp. date 7/31/2024, 500's Bottle 5211339, exp. date 7/31/2024, 100's Bottle 5211340, exp. date 7/31/2024, 100's Bottle 5211341, exp. date 7/31/2024, 100's Bottle 5211363, exp. date 8/31/2024, 100's Bottle 5220313, exp. date 2/28/2025, 500's Bottle 5220314, exp. date 2/28/2025, 500's Bottle 5220315, exp. date 2/28/2025, 500's Bottle

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-0461-2023
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: Anxiety & Sleep 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

Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

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 # 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2023, 500's Bottle 5210642, exp. date 3/31/2023, 100's Bottle 5210643, exp. date 3/31/2023, 100's Bottle 5210644, exp. date 3/31/2023, 500's Bottle 5210766, exp. date 4/30/2023, 100's Bottle 5210767, exp. date 4/30/2023, 100's Bottle 5210768, exp. date 4/30/2023, 500's Bottle 5210999, exp. date 5/31/2023, 500's Bottle 5211000, exp. date 5/31/2023, 500's Bottle 5211001, exp. date 5/31/2023, 500's Bottle 5211002, exp. date 5/31/2023, 500's Bottle 5211003, exp. date 5/31/2023, 500's Bottle 5211004, exp. date 6/30/2023, 500's Bottle 5211005, exp. date 6/30/2023, 500's Bottle 5211006, exp. date 6/30/2023, 500's Bottle 5211055, exp. date 6/30/2023, 500's Bottle 5211332, exp. date 7/31/2024, 500's Bottle 5211333, exp. date 7/31/2024, 500's Bottle 5211339, exp. date 7/31/2024, 100's Bottle 5211340, exp. date 7/31/2024, 100's Bottle 5211341, exp. date 7/31/2024, 100's Bottle 5211363, exp. date 8/31/2024, 100's Bottle 5220313, exp. date 2/28/2025, 500's Bottle 5220314, exp. date 2/28/2025, 500's Bottle 5220315, exp. date 2/28/2025, 500's Bottle

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	Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical	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

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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 Alprazolam recalls

All 23

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by ViatrisXanax	Viatris	Potency & Assay	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 0.5mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 0.25mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 1 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
11 May 2022Drug	CLASS II	alprazolam XR extended-release tablets, 3 mg recalled by ViatrisAlprazolam	Viatris	Potency & Assay	Nationwide