Use caution Drug recall · FDA · Published December 14, 2018

Cipla Recalls Nevirapine 400mg Due to Dissolution Failure

Cipla Limited recalls specific lots of Nevirapine Extended Release Tablets, 400 mg, because they failed dissolution specifications. Check your bottle's lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0382-2019Drug Cipla ›

Use caution until it’s fixed

Failed Dissolution Specifications.

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Contact the company

Recalling firmCipla LimitedL129 - 146 S - 103 - 105 S - 107 - 112 L147 - L147/1/2/3 L147/A · Vasco Da Gama, India

✎ GovInfoNow plain-language explainer

Cipla Limited is recalling a specific batch of Nevirapine Extended Release Tablets, 400 mg, manufactured in India and distributed nationwide. The recall was initiated because the product failed to meet required dissolution specifications. This means the medication may not release its active ingredient properly, potentially affecting how well it works for patients. Read more at govinfonow.com/recall/39370-cipla-recalls-nevirapine-400mg-due-to-dissolution-failure.

Source Summary by GovInfoNow · govinfonow.com/recall/39370-cipla-recalls-nevirapine-400mg-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0382-2019

Cite this page

“Cipla Recalls Nevirapine 400mg Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39370-cipla-recalls-nevirapine-400mg-due-to-dissolution-failure. Based on FDA recall #D-0382-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2019%22&limit=1).

The FDA announced on 2018-12-14 that Cipla Limited voluntarily recalled Nevirapine Extended Release Tablets due to failed dissolution specifications. The recall affects 4,800 bottles distributed nationwide within the United States.

How to tell if you have it

Brand: Cipla
Product: Nevirapine Extended Release Tablets, 400 mg, 30-count bottle
NDC: 69097-403-02
Lot #: GG80257
Expiration: 12/2019

The hazard

The product failed dissolution specifications. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Cipla Limited has two other recalls on record since 2015-04-24, including a 2025-10-31 Phytonadione Injectable Emulsion recall for stability issues and a 2015-04-24 Levalbuterol Inhalation Solution recall due to impurities. Other recent recalls of similar products include Teva Metoprolol Succinate Extended-Release Tablets Recall (2026-01-29), Teva Metoprolol Succinate Tablets Recall (2026-01-29), and Cipla Nilotinib 200mg Capsules Recall (2026-02-18).

How to tell if you have this one

Look for a 30-count bottle of Nevirapine Extended Release Tablets, 400 mg, Rx Only. The manufacturer is Cipla Ltd., Verna Goa, India. Check the label for NDC 69097-403-02, Lot # GG80257, and an expiration date of 12/2019.

Brand
Cipla
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check your medication
Verify if your bottle matches NDC 69097-403-02, Lot # GG80257, and Exp. 12/2019.
Contact your pharmacist
Speak with your healthcare provider or pharmacist to determine the next steps for your treatment plan.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Dec 14, 2018Firm started the recall
Dec 26, 2018Published in FDA’s Enforcement Report
Jan 16, 2019FDA classified it Class II
Jul 8, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where was this product sold?

The product was distributed nationwide within the United States.

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Link to this recall

<a href="https://govinfonow.com/recall/39370-cipla-recalls-nevirapine-400mg-due-to-dissolution-failure">Cipla Recalls Nevirapine 400mg Due to Dissolution Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0382-2019 (December 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0382-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.