Hiprex 1g Class 4 Defect: Braille Error States 1mg Instead of 1g
Summary
Doncaster Pharma Limited has notified the MHRA of a Braille embossing error on outer packaging for certain parallel imported batches of Hiprex 1g tablets (methenamine hippurate). The embossed Braille incorrectly states the strength as 1mg rather than 1g, though all printed text correctly shows 1g. Five batches are affected, distributed between October 2025 and March 2026, all expiring April 2028. The MHRA has classified this as a Class 4 defect and is not recalling the affected products as they remain within specification with no quality issues. Healthcare professionals are advised to explain the error to patients who rely solely on Braille when reading medicine cartons.
“The impacted products remain within specification and there is no issue with product quality. As a result, the affected batches are not being recalled.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
Doncaster Pharma Limited has reported a Class 4 medicines defect to the MHRA regarding Braille embossing on outer packaging of Hiprex 1g tablets. The embossed Braille text incorrectly states the strength as 1mg when it should read 1g. The printed text on outer packaging, immediate packaging, and Patient Information Leaflet all correctly state 1g. Five parallel imported batches are affected, distributed between October 2025 and March 2026.
Healthcare professionals and dispensing GP practices should be aware that no product recall is being issued as the products remain within specification. Professionals should provide explanation to visually impaired patients who rely solely on Braille when requested. Patients are advised to take no action and continue their medication as prescribed, with any concerns to be addressed at the point of dispensing.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM).
From: Medicines and Healthcare products Regulatory Agency Published 22 April 2026 Message type: Medicines recall/notification Medical specialty: Dispensing GP practices and Pharmacy Issued: 22 April 2026
DMRC reference number
DMRC- 39194203
Marketing Authorisation Holder
Doncaster Pharma Limited
Medicine Details
Hiprex 1g tablets
PLPI: 56830/0284
Active ingredient: methenamine hippurate
SNOMED code: 44366111000001107
GTIN: N/A
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 251352/BA | 04/2028 | 100 tablets | 27/10/2025 |
| 251358/BA | 04/2028 | 100 tablets | 21/01/2026 |
| 252137/BA | 04/2028 | 100 tablets | 04/02/2026 |
| 252137/BB | 04/2028 | 100 tablets | 11/03/2026 |
| 251358/BB | 04/2028 | 100 tablets | 27/03/2026 |
Background
Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of the above mentioned parallel imported batches of Hiprex 1 g tablets (POM). It was identified that the embossed Braille text on the outer packaging incorrectly states the strength as 1mg. The printed text on the outer packaging, immediate packaging and Patient Information Leaflet (PIL) correctly state the strength as 1g.
| Correct Braille | Incorrect Braille | |
|---|---|---|
| The correct Braille message should read: | The incorrect Braille message reads as: |
Advice for Healthcare Professionals:
The impacted products remain within specification and there is no issue with product quality. As a result, the affected batches are not being recalled.
Healthcare professionals should, if requested, explain the Braille errors to patients who rely solely on Braille when reading medicine cartons. As the products are supplied in a single strength, there is no risk of dosing errors arising from the Braille issue.
Advice for Patients:
No action is needed from patients, continue to take medication from these batches of tablets. The actions will be controlled by the healthcare professionals who prescribe or dispense the medication who will provide appropriate support at the time of dispensing, where required.
Patients who experience adverse reactions or have any questions about their 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 regulatory@doncasterpharma.co.uk or quality.enquiries@doncasterpharma.co.uk, or telephone 01302 365 000.
For stock control enquiries, please email commercial@doncasterpharma.co.uk, or telephone 01302 365 000.
Recipients of this Medicines Notification 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
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Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
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Published 22 April 2026
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