Birth control tablets recalled nationwide for temperature storage deviation
Lillow oral contraceptive tablets (batch A5921) have been recalled nationwide by Cardinal Healthcare due to exposure to temperatures outside labeled storage conditions.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a CGMP deviation with no reported adverse events or injuries. No confirmed efficacy loss has been documented in the source material.
Plain-English summary
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg is being recalled nationwide. The recall affects batch A5921 distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ.
Cardinal Healthcare, the manufacturer, has initiated this recall due to Current Good Manufacturing Practice (CGMP) deviations. Products in batch A5921 were exposed to temperatures outside the labeled storage conditions.
Patients taking Lillow should check their medication to see if it is from batch A5921. If so, they should contact their healthcare provider or pharmacist to discuss appropriate next steps. Patients should not stop taking the medication without consulting their healthcare provider first.
The recalled product
- Product
- Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 1
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 (1)
- Batch A5921
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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