Report a product defect: veterinary medicine
How a marketing authorisation holder should report a defect with a veterinary medicine.
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 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 . 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
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Table updated to include Scabigard and Hibiwash.
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Table updated to include Gonavet Veyx and Maprelin.
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Table updated to include recall notice for Crovect 1.25% w/v Pour-on Solution for Sheep.
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Table updated to include Anesketin 100 mg/ml Solution for Injection for Dogs, Cats and Horses recall.
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Updated table of recalled products to include Alamycin LA Injection, Pen + Strep Injection.
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Updated to include NT Labs Methylene Blue recall.
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Table updated to include Revozyn recall.
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Added Prednicare 1mg tablets.
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Milprazon Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg product defect recall added.
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Ronidazole Capsules - Product defect recall alert has been added to the List of recalled products table
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Updated table to include recall notices for Kexxtone 32.4g Continuous-Release Intraruminal Device for Cattle and Aquacare Swimbladder Treatment.
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Added recall for Fleasolve 134 mg Spot-on Solution for Medium Dogs
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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
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Anesketin 100 mg/ml 5ml Solution for Injection product defect recall added
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Narketan-10 and listed King British Medicines product recall notices added.
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Guidance reviewed and updated to include addition process information.
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List of batch recalls updated
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Product list updated: Johnson’s Small Animal Insecticidal Shampoo 125ml and Dog Flea Shampoo 200ml Product defect recall added
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Product defect recall added for Clavudale 40 mg/10 mg tablets for cats and dogs
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Batch recall for Prednidale 5 mg Tablets added
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Product added: Flukiver 5% w/v Oral Suspension - product defect batch recall alert
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Product defect batch recall alert Baytril Piglet Doser 0.5% Oral Solution added.
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Product recall list for last 12 months updated
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Update to table of recalled products
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Update table of recalled products
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Updated table of recalled products: Lydaxx 100 mg/ml solution for injection for cattle, pigs and sheep Ketofen 10% Solution for Injection
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Salmovac 440 added to list of recalled products
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Product defect recall alert added for Prid Delta 1.55 g Vaginal Delivery System for Cattle.
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Updated to include January 2021 notices
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Table of recalled products updated
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Updated table of recalled products
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Added Johnson’s 4Fleas 80mg Spot-on Solution for Cats to table of recalled products
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Added Foston 20% w/v Solution for Injection - Product defect recall alert
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Updated table of recalled products
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Updated table of recalled products
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Update to the table of recalled products - Clavubactin
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Recall notification for Isathal 10mg/g eye drops added
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List of recalled products updated
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Updated List of recalled products
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Recalled products table updated
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Updated list of recalled products
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List of recalled products updated
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Updated Batch Recall table
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Updated Batch Recall table
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Updated Batch Recall table.
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Updated Batch Recall table
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Updated Product Defect Report form
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Updated Analysis of Quality Product Defects received by the VMD in 2016-17 Report
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Oxytobel 10IU/ml added to the list of recalled products.
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Batch Recall Table updated
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Added link to analysis of reports received by the VMD in 2016-17
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Batch Recall table updated
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Updated table
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Updated recalled product list
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Updatded recalled products list
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Product Defect/Batch Recall Report Template (Recall 2) with the latest version
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Propofol Emulsion for Injection 1.0% w/v added to the recall table
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Product recall list updated
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Updated list of recalled products
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Updated Recall2 Form
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Updated Product defect report form added
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Table updated with the latest information
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Batch recall table has been updated.
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Product recall list updated
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First published.