Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC
Drug recall: Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, I
SUN PHARMACEUTICAL INDUSTRIES INC (Princeton, NJ) initiated this drug recall on 15 Mar 2021; FDA lists 1 product record under event 87545, classified Class II.
FDA defines Class II as 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. 60% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 6 Jun 2023. Initiation: voluntary: firm initiated. SUN PHARMACEUTICAL INDUSTRIES INC has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ.
Reason for recall
"Failed Impurities/Degradation Specifications"
Distribution
"NJ"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0320-2021 | 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. | 91,211 syringes | Class II | Terminated | 14 Apr 2021 |
Context
Other enforcement events for SUN PHARMACEUTICAL INDUSTRIES INC
All 94 events for SUN PHARMACEUTICAL INDUSTRIES INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "NJ"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Jun 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.