MHRA Class 3 Medicines Recall: Atorvastatin 20mg and 80mg Film-coated Tablets (Sun Pharmaceutical Industries Limited)
Drug Alert Number: EL(25)A/48
Date issued: 11 November 2025
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
DMRC reference number: DMRC – 37494064
Marketing Authorisation Holder: Sun Pharmaceutical Industries Limited
Medicine Details
Atorvastatin 20 mg Film-coated Tablets (PL: 14894/0714)
Active ingredient: atorvastatin calcium trihydrate
SNOMED code: 22940911000001103
GTIN: 05015525012327
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| PTF6133A | 30/11/2027 | 28 | 09/09/2025 |
Atorvastatin 80 mg Film-coated Tablets (PL: 14894/0716)
Active ingredient: atorvastatin calcium trihydrate
SNOMED code: 22941511000001103
GTIN: 05015525012341
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| PTF5991D | 30/11/2027 | 28 | 19/08/2025 |
| PTF5991F | 30/11/2027 | 28 | 27/08/2025 |
Background
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View full alert here.
Advice for Healthcare Professionals to Provide to Patients
Patients should continue to take medicines as prescribed by your healthcare professional. The recall is being actioned at the wholesaler level as a precautionary measure. No complaints of harm or lack of efficacy have been received from patients regarding this batch.
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 Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.
For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.
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