CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Nevirapine Extended Release Tablets, 400 mg recalled by Cipla
Cipla is recalling Nevirapine Extended Release Tablets, 400 mg, distributed nationwide in the US. The recall was initiated on 14 Dec 2018 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-0382-2019
- FDA event ID
- 81795
- Recalling firm
- Cipla, Vasco Da Gama
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2018
- FDA classified
- 16 Jan 2019
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 14 Dec 2018 | Recall initiated by company | |
| 26 Dec 2018 | Published in enforcement report | +12 days |
| 16 Jan 2019 | Classified by FDA | +21 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
Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02
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 #: GG80257, Exp. 12/2019
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.
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