MHRA Class 3 Medicines Recall: Bayer Plc, Various Products

MHRA Class 3 Medicines Recall:Bayer Plc, Various Products

Drug Alert Number: EL(26)A/12

Date issued: 12 March 2026

Bayer Plc is recalling all stock of the products listed in this notification as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.

DMRC reference number: DMRC- 38673150

Marketing Authorisation Holder: Bayer Plc

Medicine Details

Gastrografin gastroenteral solution

PL: 00010/0537

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 9757711000001100

GTIN: 5016703008323

Affected Lot Batch Numbers:

Medicine Details

Urografin 150 Infusion

PL: 00010/0568

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 8058511000001109 (250 ml 8058911000001102 (500 ml)

GTIN: 5016703000013 (250 ml) 5016703000983 (500 ml)

Affected Lot Batch Numbers:

Medicine Details

Urografin 150 Injection

PL: 00010/0569

Active ingredients: meglumine amidotrizoate and sodium amidotrizoate

SNOMED code: 8057711000001100 (10 ml) 8058111000001100 (20 ml)

GTIN: 5016703000860 (10 ml) 5016703000976 (20 ml)

Affected Lot Batch Numbers:

Background

Bayer Plc is recalling all stock of the above products as a precautionary measure due to the identification of an impurity above the acceptable limit. The recall is at pharmacy and wholesaler level.

Advice for healthcare professionals

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

View full alert here.

Advice for Healthcare Professionals to Provide to Patients

No action is required by patients. The medication is administered by healthcare professionals for use during radiological examinations. The recall is at the wholesaler and pharmacy level.

The products are being recalled out of an abundance of caution, no reports of patient harm have been received from patients relating to this defect.

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 medical.information@bayer.co.uk, or telephone 0118 206 3116.

For stock control enquiries please email orders-uk@bayer.com, or telephone 0118 206 3131.

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