The Recall Desk
ModerateFDA (Drugs)·D-0648-2016·Announced 2016-02-10

Pfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells

Pfizer is recalling specific lots of Lyrica (pregabalin) 50 mg capsules due to the potential presence of deformed or damaged capsules.

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 reasonable probability of temporary or medically reversible health consequences. The defect is physical (deformed/damaged capsules) rather than a high-risk chemical contamination or mislabeling of a common allergen, fitting the Moderate severity criteria for low-risk physical defects.

Plain-English summary

Pfizer Inc. is recalling specific lots of Lyrica (pregabalin) 50 mg capsules, 90-count bottles. The recall is being conducted due to the potential presence of deformed or damaged capsules in the product.

The affected product is identified by Lot # M07861 with an expiration date of 05/2018. A total of 30,672 bottles were distributed nationwide and in Puerto Rico. The product is distributed by Parke-Davis, a division of Pfizer Inc.

Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
LYRICA (PREGABALIN)
Brand
LYRICA
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
30,672

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 #: M07861
  • Exp 05/2018

UPCs (1)

  • 0300711012683

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Pfizer 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 2 products in this recall →

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Same hazard · physical defect

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