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Amantadine hydrochloride Renata 100 mg Capsules, hard and Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (EMP)-Batch recall

25/06/2026
Medicines for animal use Recall

We wish to advise you that the batches listed below of Amantadine hydrochloride Renata 100 mg Capsules, hard (PA 22865/005/001) and Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (EMP) are being recalled with immediate effect.


This recall is going to veterinarian level only. The reason for the recall is that Amantadine products are for human use and are prohibited as a veterinary treatment, in accordance with Regulation (EU) 2022/1255.

The recall letter (dated 24 June 2026) can be found in the Documents section at the bottom of this page.

Product information

Product name
See Reference section for table of recalled products
Active substance
Amantadine hydrochloride
Manufacturer or supplier
Uniphar Group
Human or veterinary medicine
Veterinary Medicine
Target audience
Veterinary clinics
Recall level
Veterinary level

Actions to be taken

Information for Veterinarians

Veterinarians are requested to please perform the following actions:

  1. Please immediately identify and quarantine any impacted units of the above batches within your facility.
  2. Please return quarantined stock to Uniphar by 08th July 2026.
  3. If you have supplied units from the above batches to any other veterinary clinic, please forward a copy of the recall letter (in the Documents section at the bottom of this page) to them, requesting that they quarantine and return any unsold quantities to you.

Reference

 Product name

 Batch No.

 Exp. Date

Amantadine hydrochloride Renata 100 mg Capsules, hard (PA22865/005/001)

R12240061

11/2028

Amantadine hydrochloride Renata 100 mg Capsules, hard (PA22865/005/001)

R12230011

06/2026

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

5988

2027-AUG -31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

5860

2027-JUL-31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

5674

2027-MAY-31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

5427

2027-MAR-31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

5177

2026-DEC-31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

4B14

2026-NOV-30

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

4AF6

2026-OCT-31

Amantadine Hydrochloride Oral Solution USP 50 mg/5 ml (Unauthorised-EMP)

4ACC

2026-SEP-30

 

Documents

Opens in new window Amantadine - Veterinary Recall Letter - 24 June 2026 - pdf PDF : 372KB | 25/06/2026