Sun Pharma recalls Atorvastatin 20mg and 80mg Film-coated Tablets over failed dissolution tests
Certain batches of the tablets failed dissolution test results during ongoing stability studies, so they are being recalled as a precaution, and no complaints of harm have been received from patients.
What to do
Healthcare professionals should stop supplying the listed batches immediately, quarantine all remaining stock and return it to their supplier using the supplier's approved process. Patients should continue to take medicines as prescribed and seek medical attention if they have adverse reactions or questions. For enquiries, email Cserv.uk@sunpharma.com or telephone 020 8848 5050.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- Atorvastatin 20 mg Film-coated Tablets
- Hazard
- 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.
- Identifiers
- DMRC reference number: DMRC - 37494064
- PL: 14894/0714
- Active Ingredient: atorvastatin calcium trihydrate
- SNOMED code: 22940911000001103
- GTIN: 05015525012327
- MHRA reference: EL(25)A/48
- Issued
- November 11, 2025
- Published on GOV.UK
- November 11, 2025
- Listed on Recalled Today
- November 11, 2025
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from MHRA.
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
- 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
- Medicine Details
- 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.
- 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. Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information. Yours faithfully Defective Medicines Report Centre 10 South Colonnade Canary Wharf London E14 4PU Telephone +44 (0)20 3080 6574 DMRC@mhra.gov.uk
- Download document
- Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
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