Bio Products Laboratory Rabies Immunoglobulin Batch Recall - Reduced Potency

MHRA Drug & Device Alerts

Filed March 30th, 2026

Detected March 31st, 2026

Summary

MHRA issued a Class 2 medicines recall for Bio Products Laboratory Limited's batch JRC24208 of Rabies Human Normal Immunoglobulin 500IU solution for injection due to stability failure causing reduced potency. Approximately 1,414 packs distributed since October 2024 are affected, expiring April 2027. Healthcare professionals must immediately quarantine and return the affected stock. No adverse events have been reported.

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What changed

Bio Products Laboratory Limited is recalling one batch (JRC24208) of Rabies Human Normal Immunoglobulin 500IU solution for injection following a stability failure resulting in reduced potency. The batch, distributed since October 2024 with expiry April 2027, comprises 1,414 packs. This precautionary recall aims to prevent reduced clinical effectiveness; no adverse event reports have been received.

Healthcare providers must immediately stop supplying the affected batch, quarantine all stock, and return it to suppliers using approved processes. Patients who received treatment from this batch require no action as the product is administered by healthcare professionals. Suspected adverse reactions should be reported via the MHRA Yellow Card scheme. The recall reference number is DMRC-38515822.

What to do next

Immediately stop supplying batch JRC24208 of Rabies Human Normal Immunoglobulin 500IU
Quarantine all affected stock and return it to your supplier using the approved process
Report any suspected adverse reactions to the MHRA Yellow Card scheme

Source document (simplified)

Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18

From: Medicines and Healthcare products Regulatory Agency Published 30 March 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 30 March 2026

DMRC reference number

DMRC- 38515822

Marketing Authorisation Holder

Bio Products Laboratory Limited

Medicine Details

Rabies, Human normal Immunoglobulin 500IU solution for Injection

PL: 08801/0014

Active ingredient: Human Rabies Immunoglobulin

SNOMED code: 422303009

GTIN: 15019943000352

Affected Lot Batch Numbers

| Batch No. | Expiry Date | Pack Size | First Distributed |
| --- | --- | --- | --- |
| JRC24208 | April 2027 | 500 IU | October 2024 |

Background

Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency of the Human Rabies immunoglobulin. This action is intended to prevent any potential reduction in clinical effectiveness of the product. No adverse event reports have been received related to this defect.

This recall does not impact other batches manufactured that are currently on the market.

Advice for Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.

Bio Products Laboratory Limited can confirm that 1,414 packs of this batch have been released and distributed. No related adverse event reports have been received related to this defect.

Advice for Healthcare Professionals to Provide to Patients:

No action is required by patients as this product is administered by healthcare professionals only, who will ensure the affected stock is removed from use.

The recall is a precautionary measure to mitigate the risk of a loss of efficacy of the product once administered. No adverse event reports have been received related to this issue. Patients who may have received treatment from these batches will not need to take any action.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Additional information:

For all medical information enquiries and information on this product, please email medinfo@bpl.co.uk or medinfo@kedrion.com or telephone +44 (0)20 89572255, +44 (0)20 89572622 or +44 (0)20 89572200

For stock control enquiries please email bplorders@kedrion.com, or telephone +44 (0)20 89572251

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre

10 South Colonnade

Canary Wharf

London

E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk