How MAHs Report Veterinary Medicine Defects

Guidance

Report a product defect: veterinary medicine

How a marketing authorisation holder should report a defect with a veterinary medicine.

From: Veterinary Medicines Directorate Published 17 November 2014 Last updated 2 April 2026
— See all updates Get emails about this page Print this page

Reporting a product defect

Only authorised veterinary medicines that are of suitable quality, safety and efficacy are permitted on the market. To ensure protection of animal and public health, we assess information about potentially defective products reported to us.

We receive reports by Marketing Authorisation Holders (MAHs) or by another National Competent Authority (NCA), via a Rapid Alert Notification (RAN) or a Good Manufacturing Practice statement of non-compliance.

If a pharmaceutical company becomes aware of an issue or defect with one of their products or a batch of product they must report this to the Veterinary Medicines Directorate (VMD).

Complete the Product defect report form (ODT, 38.7 KB) and send it to rapidalert@vmd.gov.uk.

If the product or batch is likely to be recalled due to the defect you must contact the VMD to discuss the issue. Where appropriate give details of the level of recall, for example wholesaler level, veterinary practice level.

All other reporters should contact the marketing authorisation holder.

List of recalled products

Products recalled in the UK in the last 12 months.

Product	Recall Date	Batch No.	Level of Recall	Problem
Scabigard Suspension for Cutaneous Administration - product defect recall alert	02.04.26	7482095A01 7482095A02 7482095B01 7482095B02 7482095D01 7482095D02 7482096A01 748209701 748209702	Wholesaler Veterinarian End User	Affected batches may not demonstrate the expected signs of take following administration
Warning relating to veterinary use of Hibiwash 4% w/v Cutaneous Solution Clorhexidine gluconate 500 ml	23.03.26	5156042, 5156043, 5156093	Veterinarian	Detection of BCC in the purified water system during routine microbiological testing at their manufacturing facility
Batch recall alert - Folltropin 700 IU Powder and Solvent for Solution for Injection	14.11.25	4K128A	Veterinarian	Presence of particles in stored samples of the diluent
Batch recall alert for Vey Tosal 100 mg/ml + 0.05 mg/ml Solution for Injection	03.11.25	23K019	Veterinarian	Presence of particles observed in the batch
Recall alert - Catophos 100 mg/ml + 0.05 mg/ml Solution for Injection	30.10.25	23K206	Veterinarian	Visible particles present in the vials
Neptra Ear Drops Solution for Dogs - Product defect recall alert	30.10.25	E154100A	Retailer	Distributed by one UK wholesaler after batch expiry
Product defect recall alert for four products by Dechra Pharmaceuticals PLC	22.10.25	24K017, 25B254, EB, ED, EF, FA, FC, 24J014, 151300, 152435	Wholesaler	Increased risk of microbial contamination in the aseptically manufactured products at the site of the contracted manufacturer
Product defect recall alert for Busol and Procapen Injector	22.10.25	24H264, 25C204, 24F174, 25B193	Wholesaler	Increased risk of microbial contamination in the aseptically manufactured products at the site of the contracted manufacturer
Gonavet Veyx 50 micrograms/ml Solution for Injection for Cattle, Pigs and Horses - Product defect recall	14.10.25	24B072 24G253	Wholesaler	Increased risk of microbial contamination in the aseptically manufactured products at the site of the contracted manufacturer
Maprelin 75 µg/ml Solution for Injection for Pigs - Product defect recall	14.10.25	24B067 24E271	Wholesaler	Increased risk of microbial contamination in the aseptically manufactured products at the site of the contracted manufacturer
Crovect 1.25% w/v Pour-on Solution for Sheep - Recall alert	04.08.25	30297	Wholesaler	The colour of the product is paler than usual and does not leave a stain on treated sheep.
Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses - Recall alert	17.07.25	148221, 149367, 154100, 156456	Veterinarian	Identification of visible particles present in the vials.
Product defect recall alert – Alamycin LA Injection, Pen + Strep Injection	05.06.25	4491-600C 5033-51A	Wholesaler	Precautionary measure.
NT Labs Methylene Blue - Product defect recall alert	08.04.25	21474 & 22055	Wholesaler	Composition stated on the bottle label & carton is incorrect.

What issues are classed as a product defect

These could include:

• incorrect labelling, such as product strength, name of ingredients
• misinformation or lack of information on the packaging or leaflets
• incorrect manufacture, such as strength of the ingredients or an issue with the container
• contamination of any kind
• stability, such as expiry

• counterfeit or deliberately tampered with product
  A suspected defective product is one which:

• proves to be harmful under normal conditions of use

• has a composition that’s not as declared

• has not had the controls on the finished product or during the manufacturing processes or other requirement of the manufacturing authorisation fulfilled
  In cases of serious risk to animal or public health, we may instruct MAHs to suspend further supply of a product and/or to recall one or more defective batches from the market.

Legal requirement

The holder of an authorisation referred to in Article 44 of Directive 2001/82/EC (for veterinary products) is required by Article 13 of Directive 91/412/EEC (for veterinary products) to implement an effective procedure for the recall of defective products. The authorisation holder is required to notify the relevant Competent Authority of any defect that could result in a recall and indicate, as far as possible, the countries of destination of the defective product.

For information on human medicines please visit the MHRA Safety Information page.

Procedure for submitting product defect reports

MAHs should submit details of suspected defective reports to us on the Product defect report form (ODT, 38.7 KB). The form requires details of:

• The product name and its marketing authorisation (MA) number
• The name of the MAH or distributor
• The details of the manufacturing site(s) including the batch certification/release/importation sites
• The batch number and expiry date of the product
• The nature of the defect
• Distribution details
• The action taken or being taken by the MAH Send the completed form to rapidalert@vmd.gov.uk.

The product defect report will be logged and circulated to our Assessment Group comprising Quality, Safety & Efficacy assessors, GMP inspectors, pharmacovigilance vets and other experts for their comments.

The Assessment Group’s comments and requests for additional information are communicated to the MAH.

Correspondence will continue until we are satisfied that the MAH has effectively dealt with the product defect. This may include a product or batch recall, submission of a variation or even expiry of a product’s authorisation.

Classification of Product Defects

Product defects are classified using the following high level terms (HLTs):

High Level Term (HLT)	Includes (Secondary details)
OOS	Product is Out Of Specification (OOS) including: dissolution test results, ongoing stability (OGS), deviation from MA
Contamination	Microbial cross-contamination, Chemical cross-contamination, Physical cross-contamination, Lack of sterility, Suspected transmission of an infectious agent via product
Packaging	Defective package including blister packaging, closure or seal issue, packaging quantity issue, change not in accordance with MA, coring (crumbling/breakage of the rubber/other stopper when broached)
Labelling	Product information literature issues including incorrect or missing information on the label of the immediate or outer packaging, package insert or leaflet
API	Active Pharmaceutical Ingredient (API; also referred to as active substance) doesn’t meet required specification, including those notified via Statements of Non-Compliance
Other	Any other defect, such as, counterfeit/fraudulent product, product not manufactured in accordance with Good Manufacturing Practice (GMP). Pharmacovigilance (PhV) issues including: adverse event, adverse reaction, suspected lack of expected efficacy. Physical issues including: product coating, product deposit, product dosage form, product gel formation

Product Recalls

Where a suspected defective product is considered to pose a serious risk to animal or public health we will normally instruct the MAH to withdraw the affected product from the market, that is, to initiate a product recall. The recall level will depend on the seriousness of the risk. Defects are classified Class 1 to 3 as below:

• Class 1 (Critical): the defect presents a life threatening or serious risk to health
• Class 2 (Major): the defect may cause mistreatment or harm to the animal but it is not critical
• Class 3 (Minor): the defect is unlikely to cause harm to the patient and typically arises from non-compliance with the MA or the product’s specification Class 1 defects will normally result in a product recall to the end-user, such as to farmer or pet owner.

Class 2 will normally result in a recall to retailer level, such as veterinary surgeon, pharmacist or suitably qualified person (SQP).

Class 3 defects may result in a recall to wholesale dealer although in most cases no recall is considered necessary.

For Class 1 and 2 recalls we will also issue a rapid alert notification (RAN) in accordance with the procedure described in the EMA’s Compilation of Community Procedures on Inspections and Exchange of Information.

In the case of Class 1 recalls, we send a RAN to other national competent authorities including EEA member States, PIC/S, EDQM, WHO, FDA and MRA partners, irrespective of whether the product/batch was exported to that country.

For Class 2 recalls, we send a RAN only to those national competent authorities where we know the batch has been distributed. We generally do not send a RAN for Class 3 recalls.

In some cases MAHs will themselves propose a product recall but in such circumstances the recall and the level must still be authorised by us.

All product recalls are published on GOV.UK and a 12-month rolling list is published on this page.

Contact

By email: rapidalert@vmd.gov.uk

Alternatively, submit a call back request form for the Inspections team.

Updates to this page

Published 17 November 2014 Last updated 2 April 2026 show all updates
1.
2 April 2026

Table updated to include Scabigard and Hibiwash.
2.
16 October 2025

Table updated to include Gonavet Veyx and Maprelin.
3.
5 August 2025

Table updated to include recall notice for Crovect 1.25% w/v Pour-on Solution for Sheep.
4.
21 July 2025

Table updated to include Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses recall.
5.
6 June 2025

Updated table of recalled products to include Alamycin LA Injection, Pen + Strep Injection.
6.
10 April 2025

Updated to include NT Labs Methylene Blue recall.
7.
26 March 2025

Table updated to include Revozyn recall.
8.
25 September 2024

Added Prednicare 1mg tablets.
9.
9 August 2024

Milprazon Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg product defect recall added.
10.
7 August 2024

Ronidazole Capsules - Product defect recall alert has been added to the List of recalled products table
11.
2 August 2024

Updated table to include recall notices for Kexxtone 32.4g Continuous-Release Intraruminal Device for Cattle and Aquacare Swimbladder Treatment.
12.
5 July 2024

Added recall for Fleasolve 134 mg Spot-on Solution for Medium Dogs
13.
27 March 2024

Purevax® RCP FeLV lyophilisate and solvent for suspension for injection, Purevax® RCP lyophilisate solvent for suspension for injection, Eurican Herpes 205 Powder and Solvent for Emulsion for Injection added to List of recalled products table
14.
21 March 2024

Anesketin 100 mg/ml 5ml Solution for Injection product defect recall added
15.
21 February 2024

Narketan-10 and listed King British Medicines product recall notices added.
16.
22 September 2023

Guidance reviewed and updated to include addition process information.
17.
16 June 2023

List of batch recalls updated
18.
26 May 2023

Product list updated: Johnson’s Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml Product defect recall added
19.
2 May 2023

Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs
20.
9 March 2023

Batch recall for Prednidale 5 mg Tablets added
21.
13 February 2023

Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert
22.
3 February 2023

Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.
23.
9 January 2023

Product recall list for last 12 months updated
24.
15 December 2021

Update to table of recalled products
25.
16 November 2021

Update table of recalled products
26.
20 August 2021

Updated table of recalled products:
Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep

Ketofen 10% Solution for Injection
27.
17 June 2021

Salmovac 440 added to list of recalled products
28.
28 May 2021

Product defect recall alert added for Prid Delta 1.55 g Vaginal Delivery System for Cattle.
29.
22 January 2021

Updated to include January 2021 notices
30.
14 October 2020

Table of recalled products updated
31.
24 September 2020

Updated table of recalled products
32.
7 September 2020

Added Johnson’s 4Fleas 80mg Spot-on Solution for Cats to table of recalled products
33.
11 May 2020

Added Foston 20% w/v Solution for Injection - Product defect recall alert
34.
16 March 2020

Updated table of recalled products
35.
27 February 2020

Updated table of recalled products
36.
29 January 2020

Update to the table of recalled products - Clavubactin
37.
5 September 2019

Recall notification for Isathal 10mg/g eye drops added
38.
26 June 2019

List of recalled products updated
39.
21 May 2019

Updated List of recalled products
40.
28 March 2019

Recalled products table updated
41.
21 January 2019

Updated list of recalled products
42.
6 December 2018

List of recalled products updated
43.
23 July 2018

Updated Batch Recall table
44.
20 June 2018

Updated Batch Recall table
45.
18 June 2018

Updated Batch Recall table.
46.
1 May 2018

Updated Batch Recall table
47.
25 April 2018

Updated Product Defect Report form
48.
28 March 2018

Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
49.
12 March 2018

Oxytobel 10IU/ml added to the list of recalled products.
50.
19 February 2018

Batch Recall Table updated
51.
13 October 2017

Added link to analysis of reports received by the VMD in 2016-17
52.
10 October 2017

Batch Recall table updated
53.
25 May 2017

Updated table
54.
28 April 2017

Updated recalled product list
55.
27 April 2017

Updatded recalled products list
56.
2 March 2017

Product Defect/Batch Recall Report Template (Recall 2) with the latest version
57.
24 February 2017

Propofol Emulsion for Injection 1.0% w/v added to the recall table
58.
1 February 2017

Product recall list updated
59.
10 January 2017

Updated list of recalled products
60.
29 December 2016

Updated Recall2 Form
61.
8 December 2016

Updated Product defect report form added
62.
25 October 2016

Table updated with the latest information
63.
14 May 2015

Batch recall table has been updated.
64.
2 April 2015

Product recall list updated
65.
17 November 2014

First published.

Sign up for emails or print this page

Get emails about this page Print this page Contents

Related content