Medicines recallMHRA
Labetalol 200mg Tablets recalled over a quality concern
Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
Check your product
Only products that match these details are covered. Have your pack in front of you.
2 identifiers listed for this notice.
Labetalol 200mg Tablets
- Product licenceThe PL number on the carton.
- PL 11311/0376
- PL 11311/0078
What to do now
The MHRA has issued a notice about Labetalol 200mg Tablets.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/52). Quoted as issued.
Summary
Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.
The risk
DMRC reference number DMRC-33718718 Company name
Advice for healthcare professionals
Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Pharmacists should identify and immediately contact all patients who have been dispensed the impacted batch and ask them to confirm if they have remaining stock within their possession. If batch traceability information is not available, all patients dispensed this product from May 2024 should be contacted. Patients should be advised to check for this batch number and return any packs that contain the incorrect blister strips to their pharmacy.
If the pharmacist identifies any patients with an impacted product, they should also consider contacting the patient’s GP or prescriber and discuss if a new prescription is required for any ongoing resupply with other labetalol products.
Prescribers, clinicians, and other healthcare professionals involved in the prescribing/monitoring of patients who may have taken verapamil instead of labetalol, should contact their patients and/or carers directly to ensure that their treatment is reviewed, and a suitable alternative product is prescribed.
As patients may require monitoring, other clinicians and healthcare professionals may need to be involved. Healthcare professionals should be aware that only the batch stated in this notification is impacted.
The Department of Health and Social Care (DHSC) has confirmed that, as this is a prescription only medicine, a new prescription will be required for the dispensing of a replacement product. Some patients who have received this product will be entitled to free prescriptions through existing exemptions, or have arrangements in place for a pre-payment certificate and therefore a new prescription will not incur any additional costs. Where patients pay for NHS prescriptions, a charge for the new prescription will apply; patients may contact the Defective Medicines Reporting Centre if further information is required.
One batch of Labetalol 200 mg Tablets, manufactured by Tillomed Laboratories Limited, may contain the incorrect medication and is being recalled as a precautionary measure. Tillomed Laboratories have received one single market complaint where a blister strip of Vera-Til SR 240mg Tablets (Batch Number 240750) was found with the blister strips of Labetalol 200mg Tablets (Batch Number 240537).
There have been no other similar reports related to this batch, since the batch was first distributed in May 2024.This means that a limited number of packs could contain the incorrect medicine, therefore the product is being recalled as a precautionary measure.
If you were prescribed Labetalol 200mg Tablets and have received the impacted product batch (Batch Number 240537) please check that the product contains the correct medication. The batch number and expiry date information can be found on outer carton and also on the blister strips directly. If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care.
If you previously received this batch, (where known) or if you have accidentally taken Vera-Til SR 240mg Tablets please seek immediate medical advice. Please take the leaflet that came with your medicine and any remaining tablets with you. The tablet descriptions, as stated in the Patient Information Leaflets are listed.
Images showing the different medicines and where to find the batch number of the product can be found in the ‘ Download document ’ in the alert. For reference the description of the tablets are as follows:
Labetalol 200mg Tablets: Orange round biconvex film-coated tablet coded “LTL 200” on one side
Advice for patients
One batch of Labetalol 200 mg Tablets, manufactured by Tillomed Laboratories Limited, may contain the incorrect medication and is being recalled as a precautionary measure. Tillomed Laboratories have received one single market complaint where a blister strip of Vera-Til SR 240mg Tablets (Batch Number 240750) was found with the blister strips of Labetalol 200mg Tablets (Batch Number 240537).
There have been no other similar reports related to this batch, since the batch was first distributed in May 2024.This means that a limited number of packs could contain the incorrect medicine, therefore the product is being recalled as a precautionary measure.
If you were prescribed Labetalol 200mg Tablets and have received the impacted product batch (Batch Number 240537) please check that the product contains the correct medication. The batch number and expiry date information can be found on outer carton and also on the blister strips directly. If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care.
If you previously received this batch, (where known) or if you have accidentally taken Vera-Til SR 240mg Tablets please seek immediate medical advice. Please take the leaflet that came with your medicine and any remaining tablets with you. The tablet descriptions, as stated in the Patient Information Leaflets are listed.
Images showing the different medicines and where to find the batch number of the product can be found in the ‘ Download document ’ in the alert. For reference the description of the tablets are as follows:
Labetalol 200mg Tablets: Orange round biconvex film-coated tablet coded “LTL 200” on one side
Vera-Til SR 240mg Tablet: Oblong, light green, modified release, film-coated tablet with the score on both sides and smooth intact surface.
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 .
Open the MHRA notice
Questions
Why has Labetalol 200mg Tablets been recalled?
The MHRA has issued a notice about Labetalol 200mg Tablets. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.
How do I know if my medicine is affected?
Compare the product licence on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.