Lower risk Drug recall · FDA · Published June 21, 2024

Zydus Venlafaxine Capsules Recall: Failed Dissolution Testing Risk

Zydus Pharmaceuticals recalls 37.5mg Venlafaxine Extended-Release Capsules due to failed dissolution testing. These capsules may not release medication properly, risking ineffective treatment. Contact Zydus for details.

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

🇺🇸 FDA recall #D-0617-2024Drug Zydus Pharmaceuticals ›

Lower-risk recall

Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals is recalling 37.5mg Venlafaxine Hydrochloride Extended-Release Capsules because they failed dissolution testing. This means the capsules might not release medication as intended, potentially leading to ineffective treatment. Read more at govinfonow.com/recall/32616-zydus-venlafaxine-capsules-recall-failed-dissolution-testing-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32616-zydus-venlafaxine-capsules-recall-failed-dissolution-testing-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0617-2024

Cite this page

“Zydus Venlafaxine Capsules Recall: Failed Dissolution Testing Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32616-zydus-venlafaxine-capsules-recall-failed-dissolution-testing-risk. Based on FDA recall #D-0617-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2024%22&limit=1).

Zydus Pharmaceuticals (USA) Inc recalled Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, due to failed dissolution specifications, according to the FDA on June 21, 2024.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg
NDC 68382-034-16 (90-count bottles)
NDC 68382-034-10 (1000-count bottles)
Lot M213175, Exp. Date 09/2024
Lot M213176, Exp. Date 09/2024

The hazard

The recall cites out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Sun Pharmaceutical Lisdexamfetamine Capsules Recall (2025-10-28), Supernus Trokendi XR 50mg Capsules: Failed Dissolution Specifications Recall (2026-08-31), and Supernus Trokendi XR 25mg Capsules: Failed Dissolution Risk (2026-07-06).

How to tell if you have this one

Check for 90-count or 1000-count bottles labeled 37.5mg Venlafaxine Hydrochloride Extended-Release Capsules. The lot numbers are M213175 (expiring 09/2024) or M213176 (expiring 09/2024).

Brand
Zydus Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the product name, bottle count, and lot number on the packaging to confirm if it's recalled.

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 14 months after the firm started it.

Jun 21, 2024Firm started the recall
Jul 23, 2024FDA classified it Class II
Jul 31, 2024Published in FDA’s Enforcement Report
Aug 6, 2025FDA terminated the recall

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

Similar recalls

Other Zydus Pharmaceuticals recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32616-zydus-venlafaxine-capsules-recall-failed-dissolution-testing-risk">Zydus Venlafaxine Capsules Recall: Failed Dissolution Testing Risk (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-0617-2024 (June 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0617-2024 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.