The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0691-2026·Announced 2026-07-15

Clomiphene Citrate USP Active Pharmaceutical Ingredient Recalled for cGMP Deviations

Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP active pharmaceutical ingredient in three package sizes due to current good manufacturing practice (cGMP) deviations. The product was distributed in California and Florida.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for manufacturing process deviations without reported illnesses or hospitalizations. The source text does not report any adverse health effects or injuries from this product, and cGMP deviations qualify as moderate-severity manufacturing concerns under the rubric.

Plain-English summary

Shimoga Chemicals is voluntarily recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS 50-41-9) in three package sizes: 1 kg (NDC 84849-000-01), 500 g (NDC 84849-000-02), and 100 g (NDC 84849-000-03). The recall was initiated due to current good manufacturing practice (cGMP) deviations identified by the manufacturer.

The affected product was distributed in California and Florida. Multiple lots are included in this recall, with expiration dates ranging from August 2029 through January 2030.

The firm initiated this recall voluntarily on May 19, 2026, and notified the FDA by letter. The FDA classified this as a Class II recall on July 15, 2026. Healthcare professionals and organizations that received this product should stop distribution and contact Shimoga Chemicals regarding return or destruction of affected units.

The recalled product

Product
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.
Manufacturer
Shimoga Chemicals
Category
Drug — Active Pharmaceutical Ingredient
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Lot #: a) CC/004/24-25
  • Exp Date September 2029
  • CC0032526
  • Exp. Date August 2030 b) CC0442526
  • Exp. Date Aug 2030
  • CC/005/24-25
  • Exp. Date November 2029 c) CC0032526
  • Exp. Date August 2030
  • CC/009/24-25
  • Exp. Date January 2030
  • Exp. Date November 2029.

Distribution

Distributed in 2 states:

Related recalls

Same hazard · cgmp deviation

See all →

Similar recalls