The Recall Desk
ModerateFDA (Drugs)·D-0552-2021·Announced 2021-06-02

Cardinal Health Recalls LYRICA Capsules Due to Temperature Excursions

Cardinal Health is recalling 49 bottles of LYRICA (pregabalin) 200mg capsules due to intermittent exposure to temperature excursions during storage.

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: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a storage condition (temperature excursion) rather than a direct contamination or structural defect, fitting the Moderate severity criteria for low-risk quality deviations.

Plain-English summary

Cardinal Health Inc. is recalling 49 bottles of LYRICA (pregabalin) capsules, 200mg, 90-count. The product is distributed by Parke-Davis, a division of Pfizer Inc., and was manufactured in Singapore. The recall is limited to product with code CK1081.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This condition may affect the quality of the medication.

The affected product was distributed in Florida, Georgia, and South Carolina. Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement.

The recalled product

Product
LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
Affected units
49

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)

  • CK1081

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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.

See all 198 products in this recall →