Sun Pharmaceutical Industries Ganirelix Acetate Injection Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

Lot numbers, UPCs & expiration codes

Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0320-2021
Classification: Class II
Status: Terminated
Recall initiated: Mar 15, 2021
FDA report date: Apr 14, 2021
Quantity: 91,211 syringes
Recall type: Voluntary: Firm initiated
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

Original FDA data

Every field from FDA enforcement report D-0320-2021, exactly as published.

Show all FDA fields

City: Princeton
State: NJ
Status: Terminated
Country: United States
Event ID: 87545
Address: 2 Independence Way
Code information: Lots JKU1212A, JKU1503A, JKU1504A, JKU1505A, JKU1506A, Exp 03/2021; JKU3313A & JKU3314A, Exp 08/2021.
Postal code: 08540-6620
Report date: Apr 14, 2021
Product type: Drugs
Recall number: D-0320-2021
Classification: Class II
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Product quantity: 91,211 syringes
Termination date: Jun 6, 2023
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
Distribution pattern: NJ
Recall initiation date: Mar 15, 2021
Initial firm notification: Letter
Center classification date: Apr 2, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0320-2021, published Apr 14, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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