CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
Lyrica CR (pregabalin) extended release tablets, 330 mg recalled
Viatris is recalling Lyrica CR (pregabalin) extended release tablets, 330 mg, distributed nationwide in the US. The recall was initiated on 23 Aug 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0851-2021
- FDA event ID
- 88542
- Recalling firm
- Viatris, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2021
- FDA classified
- 24 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 23 Aug 2021 | Recall initiated by company | |
| 24 Sep 2021 | Classified by FDA | +32 days |
| 6 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: DN5396, EP9726, EK2417, Exp. Date August 2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Viatris
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|---|---|---|---|---|---|
| Drug | CLASS II | Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by Viatris | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Cardura XL (doxazosin) extended release tablets 8 mg recalled by ViatrisCardura | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 25 mcg recalled by Viatris | Viatris | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets USP, 75 mcg recalled by Viatris | Viatris | Potency & Assay | Nationwide |
Other Lyrica (pregabalin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lyrica (pregabalin) capsules, 200mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |