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.
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 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
- Affected units
- 9,515
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.
Related recalls
Same manufacturer · Viatris
See all →- LowCandesartan Cilexetil tablets recalled for impurity specification failure
FDA (Drugs) · 2021-09-22
Same hazard · failed dissolution
See all →- ModerateStrides Pharma Recalls Cinacalcet Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2026-10-28
- ModerateInventia Recalls Chlorthalidone Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-09-23
- ModerateMylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-09
- SevereGolden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
FDA (Drugs) · 2026-09-09
- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
Similar recalls
- HighXanax XR Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-05-18
- ModeratePfizer Recalls Lyrica Pregabalin Capsules for Deformed or Damaged Units
FDA (Drugs) · 2016-02-10
- ModerateCipla Recalls Nevirapine Extended Release Tablets for Dissolution Failure
FDA (Drugs) · 2018-12-26
- HighAlprazolam XR Extended-Release Tablets Recalled Due to Dissolution Failure
FDA (Drugs) · 2022-05-11
- ModeratePfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells
FDA (Drugs) · 2016-02-10
- ModerateMylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2017-05-31