Sun Pharmaceutical Atorvastatin 40mg Tablets Recall: Latex Contamination Hazard
Sun Pharmaceutical recalls 40mg Atorvastatin tablets with latex contamination. Foreign latex from gloves found in one lot. Stop using if you have this specific batch.
Use caution until it’s fixed
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 40mg Atorvastatin Calcium tablets that contain latex from a foreign substance. This could cause allergic reactions in people sensitive to latex, especially those with severe allergies. Read more at govinfonow.com/recall/37342-sun-pharmaceutical-atorvastatin-40mg-tablets-recall-latex-contamination-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/37342-sun-pharmaceutical-atorvastatin-40mg-tablets-recall-latex-contamination-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1047-2020
Cite this page
“Sun Pharmaceutical Atorvastatin 40mg Tablets Recall: Latex Contamination Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37342-sun-pharmaceutical-atorvastatin-40mg-tablets-recall-latex-contamination-hazard. Based on FDA recall #D-1047-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1047-2020%22&limit=1).
Why it’s dangerous
Latex from gloves was found in one batch of Atorvastatin tablets. This could trigger allergic reactions in people sensitive to latex, which might be severe or life-threatening.
Who’s affected
People with latex allergies, particularly those with severe reactions, are at risk. Anyone using this specific batch of tablets could be affected.
How to tell if you have this one
Check for the NDC code 63304-829-05 on the bottle. The specific lot number AA33617 was found to have latex contamination. This product was distributed in the US starting March 2021.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 63304-829-05 and lot number AA33617 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1047-2020 (March 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1047-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.