Lyrica CR 330 mg Tablets Recalled for Failed Dissolution
Viatris is recalling Lyrica CR (pregabalin) 330 mg extended-release tablets nationwide due to failed dissolution specifications that may reduce drug effectiveness.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard—failed dissolution specifications—is a quality defect that affects drug efficacy rather than an acute safety threat. Per the rubric, Class II recalls without hospitalization or injury reports typically score 2.
Plain-English summary
Viatris is recalling 9,515 bottles of Lyrica CR (pregabalin) extended-release tablets, 330 mg, distributed nationwide in the United States. The tablets affected are in 30-count bottles with NDC 0071-1029-01 and specific lot numbers DN5396, EP9726, and EK2417, with an expiration date of August 2022.
The recall was issued because the tablets failed to meet dissolution specifications. Dissolution refers to how quickly and completely a tablet breaks down and releases its active ingredient in the body. When a drug fails dissolution testing, it may not be absorbed properly, potentially reducing its therapeutic effectiveness.
The product is distributed by the Parke-Davis Division of Pfizer Inc. and is a prescription-only medication. Patients who have been taking affected bottles should consult their healthcare provider about whether their supply is included in the recall and what steps to take regarding their treatment.
The recalled product
- Product
- Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
- Manufacturer
- Viatris
- Hazard
- failed-dissolution
- reduced-efficacy
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 (4)
- Lot #: DN5396
- EP9726
- EK2417
- Exp. Date August 2022
Distribution
Distributed nationwide across the United States.
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