RecallRadar

FDA Drug recall D-0184-2024

HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick,…

On 2024-01-03 the FDA classified a Class II recall of HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick,… by Cardinal Healthcare, citing CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0184-2024
ClassificationClass II
Statusterminated
Initiated2022-01-26
Published2024-01-03
Last updated2026-09-13 11:52 UTC
CompanyCardinal Healthcare
DistributionUS

Product

HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01

Reason

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Identifiers

ndc23155-001-01
ndc23155-001-10
ndc23155-002-10
ndc23155-002-01
ndc23155-003-01
ndc23155-003-10
ndc23155-004-01
ndc23155-004-10
code_infoBatch G210553, G210551

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-0184-2024%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.