MHRA Class 3 Medicines Recall: Cyclizine Lactate 50 mg/ml Solution for injection (Orbit Pharma Limited)
MHRA Class 3 Medicines Recall: Cyclizine Lactate 50 mg/ml Solution for injection (Orbit Pharma Limited)
Drug Alert Number: EL(26)A/29
Date issued: 16 June 2026
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.
Medicine Details
Product name: Cyclizine Lactate 50 mg/ml Solution for injection (PL: 56854/0020).
Active ingredient: cyclizine lactate
SNOMED code: 45805811000001103
GTIN: 5061093630081
Affected Lot Batch Numbers
| Batch number | Expiry date | Pack size | First distributed |
| 2226016 | 31/12/2027 | 5 ampoules of 1ml | 19/05/2026 |
Background
Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site. However, a Class 3 recall is being initiated out of an abundance of caution.
Advice for Healthcare Professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View the full alert here.
Advice for Patients
No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
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 medical information enquiries and information on this product, please email customerservice@novumgen.com or telephone +44 203 096 6496.
For stock control enquiries please email Stockcontrol@novumgen.com
