MHRA Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution (Glenmark Pharmaceuticals Europe Ltd)
MHRA Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution (Glenmark Pharmaceuticals Europe Ltd)
Drug Alert Number: EL(25)A/30
Date issued: 30 June 2025
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.
DMRC reference number: DMRC-35139406
Medicine Details
Product name: Omeprazole 20 mg/15 ml Oral Solution (PL 25258/0383)
Active ingredient: Omeprazole
SNOMED code: 42444511000001102
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| 3230528 | 30/09/2025 | 14 | 29/01/2024 |
Background
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles. A root cause has identified that this is a result of an inadequate assembly of the plunger stem and the cup which could lead to a premature mixing of the two components of the medicinal product.
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 full alert here.
Advice for patients
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. 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 please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com
For stock control enquiries please email orders.uk@glenmarkpharma.com
