Sun Pharmaceutical Recalls Ganirelix Acetate Injection Due to Impurities
Sun Pharmaceutical Industries is recalling 91,211 syringes of Ganirelix Acetate Injection because the product failed impurities and degradation specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 91,211 syringes of Ganirelix Acetate Injection, 250 mcg/0.5 mL, sterile prefilled syringe. The product is distributed by Ferring Pharmaceuticals, Inc., and is manufactured in India. The recall is limited to the state of New Jersey.
The recall was initiated because the product failed impurities and degradation specifications. The affected lots are JKU1212A, JKU1503A, JKU1504A, JKU1505A, and JKU1506A with an expiration date of 03/2021, and lots JKU3313A and JKU3314A with an expiration date of 08/2021.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injection
- Hazard
- Affected units
- 91,211
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 (8)
- Lots JKU1212A
- JKU1503A
- JKU1504A
- JKU1505A
- JKU1506A
- Exp 03/2021
- JKU3313A & JKU3314A
- Exp 08/2021.
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24