Lower riskDrug recall · FDA · Published August 13, 2021
Zydus Carvedilol Tablets Recall: Foreign Paroxetine Tablets Found
Zydus Pharmaceuticals recalls 25mg Carvedilol tablets due to foreign paroxetine tablets found in some bottles. Report of two paroxetine tablets in the bottle poses a potential risk.
“Zydus Carvedilol Tablets Recall: Foreign Paroxetine Tablets Found.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35978-zydus-carvedilol-tablets-recall-foreign-paroxetine-tablets-found. Based on FDA recall #D-0753-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0753-2021%22&limit=1).
Zydus Pharmaceuticals (USA) Inc recalled Carvedilol Tablets, USP 25 mg because of the presence of foreign tablets. The Food and Drug Administration announced the recall on August 13, 2021.
How to tell if you have it
Brand: Zydus Pharmaceuticals
Product: Carvedilol Tablets, USP 25 mg
NDC: 68382-095-05
Lot code: Z006279
Expiration date: 12/31/2022
Quantity: 500 Tablets bottles
Distribution: Nationwide in the US
The hazard
The recall addresses the presence of foreign tablets and capsules. The record reports that two Paroxetine tablets were found in the bottle.
Context
GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since March 14, 2012. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (August 5, 2026), Zydus Erythromycin Tablets Recall (April 29, 2026), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (March 9, 2026). Other recent recalls of similar products include Granules Pharmaceuticals Trazodone 50mg Recall (January 26, 2026), Annora Pharma Pitavastatin Tablets 2mg Recall (February 3, 2026), and Golden State Baclofen Tablets Recall (November 26, 2025).
How to tell if you have this one
Check for bottles labeled 'Carvedilol Tablets, USP 25 mg, 500 Tablets' with NDC 68382-095-05 or Z006279, manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc.
Brand
Zydus Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Bottle
Look for the NDC code 68382-095-05 or Z006279 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0753-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0753-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.