HSA 公布 AA Pharma 盐酸羟嗪胶囊 10mg 与 25mg 共 18 个批次零售层面召回
Recall of AA Pharma Hydroxyzine Capsule 10mg and 25mg
HSA 公布对 AA Pharma 盐酸羟嗪胶囊 10mg 五个批次和 25mg 十三个批次的零售层面召回，原因是货架期标示错误。召回日期为 2026 年 5 月 12 日，召回分级为 Class 2，本地公司为 Pharmaforte Singapore Pte Ltd，注册号为 SIN04096P 和 SIN04142P。HSA 要求医院、诊所和药房停止供应受影响批次，并将剩余库存退回公司。
材料列出受影响批次清单、召回分级与处置要求，可供核对具体批号并了解新加坡零售层面召回的处理方式。
Product Recalls
12 May 2026
Audiences
Healthcare professional
Product type
Therapeutic Products
Retail-level recall of five batches of AA Pharma Hydroxyzine Capsule 10mg and thirteen batches of AA Pharma Hydroxyzine Capsule 25mg, due to incorrect shelf life.
Recall details
Date of recall: | 12 May 2026 |
Product: | AA Pharma Hydroxyzine Capsule 10mg AA Pharma Hydroxyzine Capsule 25mg |
Active Ingredient: | Hydroxyzine HCl |
Product Category: | Therapeutic product |
Registration Number: | SIN04096P SIN04142P |
Batch No.: | Please refer to Annex for the affected batches |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Pharmaforte Singapore Pte Ltd |
Description of Issue: | Product was supplied with incorrect shelf-life |
Recall Instructions: | Hospitals, clinics, pharmacies: Stop supplying the affected batch and return the remaining stocks to the company. |
Annex
List of affected batches
Product Name | Batch Number |
AA Pharma Hydroxyzine Capsule 10mg | AW6213A |
AA Pharma Hydroxyzine Capsule 10mg | AW6448A |
AA Pharma Hydroxyzine Capsule 10mg | AW8160A |
AA Pharma Hydroxyzine Capsule 10mg | AW8161A |
AA Pharma Hydroxyzine Capsule 10mg | AW8177A |
AA Pharma Hydroxyzine Capsule 25mg | AW5757A |
AA Pharma Hydroxyzine Capsule 25mg | AW5758A |
AA Pharma Hydroxyzine Capsule 25mg | AW6084A |
AA Pharma Hydroxyzine Capsule 25mg | AW6875A |
AA Pharma Hydroxyzine Capsule 25mg | AW7380A |
AA Pharma Hydroxyzine Capsule 25mg | AW7456A |
AA Pharma Hydroxyzine Capsule 25mg | AW7457A |
AA Pharma Hydroxyzine Capsule 25mg | AW8338A |
AA Pharma Hydroxyzine Capsule 25mg | AW8516A |
AA Pharma Hydroxyzine Capsule 25mg | AW8644A |
AA Pharma Hydroxyzine Capsule 25mg | AW8645A |
AA Pharma Hydroxyzine Capsule 25mg | AW8646A |
AA Pharma Hydroxyzine Capsule 25mg | AW8647A |
Note:
The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA’s request to remove products where there are issues with quality, safety or efficacy.
When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.
Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.
Class of recall
A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.
Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.
Level of recall
The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.
Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.
来源：HSA 治疗药品召回 · hsa.gov.sg