Report a product defect: veterinary medicine
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).
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.
Do not use this form to report an adverse event to a veterinary medicine or microchip; To report a suspected adverse event.
Products recalled in the UK in the last 12 months.
| Product | Recall Date | Batch No. | Level of Recall | Problem |
|---|---|---|---|---|
| Product defect recall alert – Alamycin LA Injection, Pen + Strep Injection | 05/06/25 | 4491-600C 5033-51A | Wholesaler | This recall is taken as a 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. |
| Revozyn RTU 400 mg/ml Suspension for Injection for Cattle - Recall alert | 25/03/25 | 24F042 | Wholesaler | Stability failure of the product re-suspendability. |
| Prednicare 1 mg Tablets | 25/09/24 | 24B01 | Wholesalers/ distributors, veterinarians and end-users | Presence of 5 mg tablets |
| Milprazon Chewable 12.5 mg/125 mg Film-coated Tablets for Dogs Weighing at Least 5 kg - recall | 09/08/24 | H15298 | Wholesaler | Microbiological non-compliance of this batch. |
| Ronidazole Capsules | 02/08/24 | SCP2MA365, SCP2MA732, SCP2MB491, SCP2MB604, SCP2N0843, SCP2N1963, SCP2N1845, SCP2N1844, SCP201964, SCP2N2114, SCP2N3214 | Veterinarian | Quality of the product not being guaranteed. |
| Kexxtone 32.4g Continuous-Release Intraruminal Device for Cattle | 30/07/24 | All in-date batches | Veterinarian / pharmacy level | Quality defect resulting in cases where cattle regurgitated the device whilst it contained monensin tablets |
| Aquacare Swimbladder Treatment | 29/07/24 | 24103 & 25024 | Wholesalers, retailers and end users | Label artwork is referencing the wrong data source regarding re-dosing. |
| Fleasolve 134 mg Spot-on Solution for Medium Dogs | 05/07/24 | 0552023 | Wholesaler | Low Fipronil content |
| Johnson’s 4Fleas Tablets for Cats and Kittens | 14/06/24 | E154176, 6-tablet packs | End User | Some units intended for cats packed in cartons of 4Fleas Tablets for Dogs (D085) Vm 00879/4062. These will contain the lower strength 11.4 mg tablets for cats with a possibility the product will be ineffective for dogs |
These could include:
A suspected defective product is one which:
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.
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.
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:
Send the completed form to [email protected].
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.
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 |
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 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.
By email: [email protected]
Alternatively, submit a call-back request for the Inspections team via [email protected].
