CLASS II Drug recall · Reported 9 Oct 2024 · FDA Enforcement Report
Atorvastatin Calcium Tablets, USP, 40mg recalled
Nivagen Pharmaceuticals is recalling Atorvastatin Calcium Tablets, USP, 40mg, distributed nationwide in the US. The recall was initiated on 24 Sep 2024 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-0001-2025
- FDA event ID
- 95418
- Recalling firm
- Nivagen Pharmaceuticals, Sacramento, CA
- Brand
- Atorvastatin Calcium
- Manufacturer
- NIVAGEN PHARMACEUTICALS, INC.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2024
- FDA classified
- 2 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 24 Sep 2024 | Recall initiated by company | |
| 2 Oct 2024 | Classified by FDA | +8 days |
| 9 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Product as listed by the FDA
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Is Atorvastatin Calcium Tablets, USP, 40mg recalled?
Yes. Nivagen Pharmaceuticals recalled Atorvastatin Calcium Tablets, USP, 40mg on 24 Sep 2024. The recall is Class II and its status is Terminated. Recall number D-0001-2025.
Why was it recalled?
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Which lots are affected?
Lot #: U24T0408A, Exp: 03/31/2026
Where was it sold?
Nationwide within the U.S
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.
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 40 mg recalled by Biocon PharmaAtorvastatin Calcium | Biocon Pharma | Potency & Assay | Nationwide |