Prescription atorvastatin bottles recalled for containing wrong medication
A carbamazepine (anticonvulsant) tablet was found in bottles of atorvastatin (cholesterol medication). The affected lot includes 2,328 bottles distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall involving foreign medication contamination with no reported illnesses or injuries. The presence of a different medication in prescription drug bottles creates significant risk of patient harm from inadvertent medication error. Meets rubric criteria for high-risk scenarios where injury has not yet been reported.
Plain-English summary
Nivagen Pharmaceuticals Inc is recalling Atorvastatin Calcium Tablets, USP 40 mg, due to the discovery of a carbamazepine extended-release 400 mg tablet in a 1,000-count bottle of atorvastatin. Atorvastatin is a prescription medication used to lower cholesterol; carbamazepine is an anticonvulsant used for seizure and nerve pain management. The presence of a different medication creates a serious medication safety hazard.
The recall involves approximately 2,328 bottles of the affected lot (lot #U24T0408A, expiration 03/31/2026) that were distributed nationwide within the United States.
Patients and healthcare providers who have received bottles from this lot should verify the contents. Anyone who discovers a tablet other than atorvastatin should contact their pharmacy or healthcare provider immediately. The affected bottle should be returned to the pharmacy for replacement.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Nivagen Pharmaceuticals Inc
- Category
- Drug
- Hazard
- medication-contamination
- drug-mix-up
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: U24T0408A
- Exp: 03/31/2026
UPCs (4)
- 0375834258027
- 0375834257501
- 0375834255903
- 0375834256016
Distribution
Distributed nationwide across the United States.
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