FDA Drug recall D-0837-2022

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC #…

FDA Drug
Class II
terminated
Published 2022-05-11

On 2022-05-11 the FDA classified a Class II recall of Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC #… by Macleods Pharma Usa, citing CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0837-2022
Classification	Class II
Status	terminated
Initiated	2022-04-15
Published	2022-05-11
Last updated	2026-09-13 11:52 UTC
Company	Macleods Pharma Usa
Distribution	US

Product

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Reason

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Identifiers

ndc	33342-050-07
ndc	33342-050-10
ndc	33342-050-44
ndc	33342-050-12
ndc	33342-051-07
ndc	33342-051-10
ndc	33342-051-44
ndc	33342-051-12
ndc	33342-052-07
ndc	33342-052-10
ndc	33342-052-44
ndc	33342-052-12
code_info	Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023

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-0837-2022%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.