FDA Drug recall D-0459-2023

Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1…

FDA Drug
Class II
terminated
Published 2023-03-22

On 2023-03-22 the FDA classified a Class II recall of Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1… by Breckenridge Pharmaceutical, citing CGMP Deviations: Potential risk of Cross Contamination.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0459-2023
Classification	Class II
Status	terminated
Initiated	2023-03-02
Published	2023-03-22
Last updated	2026-09-13 11:52 UTC
Company	Breckenridge Pharmaceutical
Distribution	US

Product

Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Reason

CGMP Deviations: Potential risk of Cross Contamination

Identifiers

code_info	Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date… Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date 2/28/2025; 5220559, exp. date 5/31/2025; b) 5210650, exp. date 3/31/2023, 5210651, exp. date 3/31/2023 5210652, exp. date 3/31/2023 5210653, exp. date 3/31/2023 5210674, exp. date 3/31/2023 5210732, exp. date 3/31/2023 5210733, exp. date 4/30/2023 5210753, exp. date 4/30/2023 5210902, exp. date 5/31/2023 5210903, exp. date 5/31/2023 5210904, exp. date 5/31/2023 5211231, exp. date 7/31/2023 5211281, exp. date 7/31/2024 5211282, exp. date 7/31/2024 5211283, exp. date 7/31/2024 5211284, exp. date 7/31/2024 5211336, exp. date 7/31/2024 5211337, exp. date 8/31/2024 5211338, exp. date 8/31/2024 5211462, exp. date 9/30/2024 5211463, exp. date 9/30/2024 5211464, exp. date 9/30/2024 5211465, exp. date 9/30/2024 5211516, exp. date 9/30/2024 5211644, exp. date 10/31/2024 5211645, exp. date 10/31/2024 5211690, exp. date 10/31/2024 c) 5210675, exp. date

code_info

Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date…

Lot # a) 5210673, exp. date 3/31/2023; 5210901, exp. date 5/31/2023; 5211461, exp. date 9/30/2024; 5220291, exp. date 2/28/2025; 5220559, exp. date 5/31/2025; b) 5210650, exp. date 3/31/2023, 5210651, exp. date 3/31/2023 5210652, exp. date 3/31/2023 5210653, exp. date 3/31/2023 5210674, exp. date 3/31/2023 5210732, exp. date 3/31/2023 5210733, exp. date 4/30/2023 5210753, exp. date 4/30/2023 5210902, exp. date 5/31/2023 5210903, exp. date 5/31/2023 5210904, exp. date 5/31/2023 5211231, exp. date 7/31/2023 5211281, exp. date 7/31/2024 5211282, exp. date 7/31/2024 5211283, exp. date 7/31/2024 5211284, exp. date 7/31/2024 5211336, exp. date 7/31/2024 5211337, exp. date 8/31/2024 5211338, exp. date 8/31/2024 5211462, exp. date 9/30/2024 5211463, exp. date 9/30/2024 5211464, exp. date 9/30/2024 5211465, exp. date 9/30/2024 5211516, exp. date 9/30/2024 5211644, exp. date 10/31/2024 5211645, exp. date 10/31/2024 5211690, exp. date 10/31/2024 c) 5210675, exp. date

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0459-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.