Shimoga Chemicals Clomiphene Citrate USP Recall: C G M P Deviations
Shimoga Chemicals recalls Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations. This is a drug product for medical use only.
Recall notice
cGMP deviations
Contact the company
What happened, in plain English
Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient (NDCs 84849-000-01 to 000-03) because of cGMP deviations. This product is used for medical purposes only and should be handled with care as it involves pharmaceutical quality issues. Read more at govinfonow.com/recall/31298-shimoga-chemicals-clomiphene-citrate-usp-recall-c-g-m-p.
Source Summary by GovInfoNow · govinfonow.com/recall/31298-shimoga-chemicals-clomiphene-citrate-usp-recall-c-g-m-p · Updated August 17, 2026 · FDA enforcement record: FDA #D-0691-2026
Cite this page
“Shimoga Chemicals Clomiphene Citrate USP Recall: C G M P Deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31298-shimoga-chemicals-clomiphene-citrate-usp-recall-c-g-m-p. Based on FDA recall #D-0691-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0691-2026%22&limit=1).
Why it’s dangerous
cGMP deviations refer to failures in the manufacturing process that could affect the quality, safety, and effectiveness of the drug. This means the product might not meet the required standards for medical use, potentially leading to health risks if used improperly.
Who’s affected
People who have the Clomiphene Citrate USP Active Pharmaceutical Ingredient (NDCs 84849-000-01 to 000-03) from Shimoga Chemicals in India are affected. Healthcare providers and patients using this medication are most at risk due to the cGMP deviations.
How to tell if you have this one
Check for the product names Clomiphene Citrate USP Active Pharmaceutical Ingredient with net weights of 1 kg, 500 g, or 100 g. Look for NDC numbers 84849-000-01, 84849-000-02, or 84849-000-03. The product is sold in India by Shimoga Chemicals.
- Brand
Shimoga Chemicals- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC numbers (84849-000-01, 84849-000-02, or 84849-000-03) and net weights (1 kg, 500 g, or 100 g) on the product label.
Where it went and when
Where it was distributed
Distributed in California and Florida.
FDA distribution: “CA & FL only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0691-2026 (May 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0691-2026 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.