The Recall Desk
ModerateFDA (Drugs)·D-0187-2024·Announced 2024-01-03

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.

What this means for you

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
Hazard
  • temperature-exposure

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.