Lower risk Drug recall · FDA · Published March 21, 2025

Zydus Venlafaxine 75mg Tablets Recall: Foreign Material in Some Tablets

Zydus Pharmaceuticals recalls 75mg Venlafaxine tablets due to foreign material found in one tablet. This is a prescription-only product with specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #D-0310-2025Drug Zydus Pharmaceuticals ›

Lower-risk recall

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

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 75mg Venlafaxine tablets after reports of foreign material in one tablet. This is a prescription-only medication that could pose a risk if the foreign substance causes injury during use. Read more at govinfonow.com/recall/32175-zydus-venlafaxine-75mg-tablets-recall-foreign-material-in-some-tablets.

Source Summary by GovInfoNow · govinfonow.com/recall/32175-zydus-venlafaxine-75mg-tablets-recall-foreign-material-in-some-tablets · Updated August 17, 2026 · FDA enforcement record: FDA #D-0310-2025

Cite this page

“Zydus Venlafaxine 75mg Tablets Recall: Foreign Material in Some Tablets.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32175-zydus-venlafaxine-75mg-tablets-recall-foreign-material-in-some-tablets. Based on FDA recall #D-0310-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0310-2025%22&limit=1).

The FDA announced on March 21, 2025, that Zydus Pharmaceuticals (USA) Inc voluntarily recalled Venlafaxine Tablets, USP, 75 mg due to the presence of foreign material resembling a metal shaving. The agency issued recall number D-0310-2025 for the Class II product distributed nationwide.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only
Manufacturer: Zydus Lifesciences Ltd, Ahmedabad, India
Distributor: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC: 68382-021-01
Lot #: M314265
Expiration Date: 31 October 2025
Quantity: 13,128 100-Count Bottles
Distribution: US Nationwide

The hazard

The recall addresses a product complaint regarding foreign material embedded in one tablet that resembles a metal shaving. The FDA classified the issue as Class II.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Recent Zydus recalls include a 2026-08-05 recall of Mirabegron 25mg Tablets for N-Nitroso Impurity Risk and a 2026-04-29 recall of Erythromycin Tablets for N-Nitroso-Desmethyl-Erythromycin Risk. Other recent recalls of similar products include Bionpharma Divalproex Tablets Recall (2026-06-26), Guardian Drug Family Wellness Antacid Tablets Recall (2026-05-28), and Guardian Drug Goodsense Ultra Strength Antacid Tablets Recall (2026-05-28).

How to tell if you have this one

Check for the lot number M314265 on the packaging. The product is a prescription-only medication with an expiration date of October 31, 2025.

Brand
Zydus Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number M314265 on the packaging of the Venlafaxine tablets.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 26 days after the firm started it.

Mar 21, 2025Firm started the recall
Apr 4, 2025FDA classified it Class II
Apr 16, 2025Published in FDA’s Enforcement Report

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

Similar recalls

Other Zydus Pharmaceuticals recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32175-zydus-venlafaxine-75mg-tablets-recall-foreign-material-in-some-tablets">Zydus Venlafaxine 75mg Tablets Recall: Foreign Material in Some Tablets (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-0310-2025 (March 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0310-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.