Class II · Moderate risk
ClomiPHENE Citrate Tablets
cGMP deviations: Temperature abuse
Clomiphene Citrate USP Active Pharmaceutical Ingredient
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
Drug: Clomiphene
- Recalling firm
- Shimoga Chemicals
- NDC code
- 84849-000-01
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0691-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Clomiphene recalls
See all
Class III · Low risk
ClomiPHENE CITRATE Tablets
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class II · Moderate risk
Clomiphene Citrate active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other cgmp deviation recalls from 2026
All cgmp deviation recalls
Class II · Moderate risk
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Class II · Moderate risk
Broadway Joe's Pain Cream
CGMP Deviations: Potential contamination of raw material
Class II · Moderate risk
Menow Sunscreen Pressed Powder Spf35 PA+++
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Class II · Moderate risk
Carbamazepine Tablets
CGMP deviations: tablets with black specks.
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