CLASS II ONGOING Drug recall · Reported 9 Apr 2025 · FDA Enforcement Report
Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon Pharma
Biocon Pharma is recalling Atorvastatin Calcium Tablets USP 40 mg, distributed nationwide in the US. The recall was initiated on 17 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0306-2025
- FDA event ID
- 96496
- Recalling firm
- Biocon Pharma, ISELIN, NJ
- Brand
- Atorvastatin Calcium
- Manufacturer
- Biocon Pharma Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Mar 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 17 Mar 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +11 days |
| 9 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed dissolution specifications: lower than specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Where it was distributed
U.S.A. nationwide
Questions about this recall
Is Atorvastatin Calcium Tablets USP 40 mg recalled?
Yes. Biocon Pharma recalled Atorvastatin Calcium Tablets USP 40 mg on 17 Mar 2025. The recall is Class II and its status is Ongoing. Recall number D-0306-2025.
Why was it recalled?
Failed dissolution specifications: lower than specifications
Which lots are affected?
Lot#: AVC24035, Exp 03/31/26
Where was it sold?
U.S.A. nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biocon Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Posaconazole Delayed-Release Tablets, 100 mg recalled by Biocon PharmaPosaconazole | Biocon Pharma | Potency & Assay | Nationwide |
Other Atorvastatin recalls
All 40| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin Calcium | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Atorvastatin Calcium Tablets, USP, 40mg recalledAtorvastatin Calcium | Nivagen Pharmaceuticals | Other | Nationwide |