Medicines defect noticeMHRA
Dropodex 0.1% w/v Eye Drops, solution defect notice over a strength or dose problem
Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information.
Check your product
Only products that match these details are covered. Have your pack in front of you.
31 identifiers listed for this notice.
Dropodex 0.1% w/v Eye Drops, solution 1 carton containing 20 single-dose units
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- C361X
- C361Y
- D361A
- D361B
- D361C
- E361A
- E361F
- E361D
- E361E
- E361C
- E361G
- E361H
- E361L
- E361M
- F361A
- ExpiryOn the carton, blister or label.
- 31 Mar 2026
- 31 Jul 2026
- 31 Jan 2028
- 29 Feb 2028
- 31 May 2028
- 30 Jun 2028
- 31 Jul 2028
- First distributedOn the product, its label or its packaging.
- 29 Jun 2025
- 31 Jul 2025
- 04 Sep 2025
- 07 Oct 2025
- 31 Oct 2025
- 28 Nov 2025
- Not yet distributed
- 25 Jan 2026
- 28 Dec 2025
What to do now
The problem with Dropodex 0.1% w/v Eye Drops, solution is strength: the dose in the affected batches may be higher or lower than the label says.
- 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. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.
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
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/10). Quoted as issued.
Summary
Rayner Pharmaceuticals limited have informed the MHRA that the batches listed in this notification do not include the concentration of phosphates in the product information.
The risk
DMRC reference number DMRC-38371734 Marketing Authorisation Holder
Advice for healthcare professionals
This medicinal product contains 1.01 mg phosphates in each 0.4 mL dose which is equivalent to 2.52 mg/mL phosphates (from 9.5 mg/mL disodium phosphate dodecahydrate). This information was not previously included in the product information and will be updated accordingly for new manufactured batches in the product information (SmPC and package leaflet) for HCPs as well as patients.
This medicinal product contains phosphates, which may lead to corneal deposits or corneal opacity when topically administered.
This medicinal product should be used with caution in patients presenting with compromised cornea and in instances where the patient is receiving polypharmacy with other phosphate-containing eye medications.
Patients should continue to use the product as instructed by their healthcare professional. The information missing from the PIL and SmPC relates only to the concentration of phosphates in the eye drops. The quality of the eye drops is not impacted by the missing information. No adverse events have been received for these batches of products. If patients have any questions about this medication, you should speak to your dispensing pharmacy in the first instance.
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 .
Advice for patients
Patients should continue to use the product as instructed by their healthcare professional. The information missing from the PIL and SmPC relates only to the concentration of phosphates in the eye drops. The quality of the eye drops is not impacted by the missing information. No adverse events have been received for these batches of products. If patients have any questions about this medication, you should speak to your dispensing pharmacy in the first instance.
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 .
Open the MHRA notice
Questions
Why has Dropodex 0.1% w/v Eye Drops, solution been recalled?
The problem with Dropodex 0.1% w/v Eye Drops, solution is strength: the dose in the affected batches may be higher or lower than the label says. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.
How do I know if my medicine is affected?
Compare the batch code, expiry and date code 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?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.