FDA Drug recall D-0461-2023

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 onl…

FDA Drug
Class II
terminated
Published 2023-03-22

On 2023-03-22 the FDA classified a Class II recall of 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 onl… by Breckenridge Pharmaceutical, citing CGMP Deviations: Potential risk of Cross Contamination.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0461-2023
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, 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.

Reason

CGMP Deviations: Potential risk of Cross Contamination

Identifiers

code_info	Lot # 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2… 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 Bottl

code_info

Lot # 5210546, exp. date 3/31/2023, 100's Bottle 5210547, exp. date 3/31/2023, 500's Bottle 5210548, exp. date 3/31/2…

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 Bottl

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-0461-2023%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.