Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported May 3, 2023
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
The recall
Sun Pharmaceutical Industries Ltd. issued this moderate-severity FDA Drug recall — Presence of Particulate Matter: A piece of glass was found in a prefilled syringe..
- Moderate
- severity level
- Class II
- classification
- May 3, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0569-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0569-2023) was formally reported on May 3, 2023, with the manufacturer initiating the action on April 19, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Sun Pharmaceutical Industries Ltd. is listed as the recalling firm, operating out of Halol, N/A. Federal records list the affected scope as 24194 Prefilled Syringes.
The documented reason for this recall is: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category — 13,821 drugs & medications recalls on record
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Affected scope
24194 Prefilled Syringes
Related Recalls
6
5 from same agency
Product description
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Reason for recall
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0569-2023 |
| Date reported | May 3, 2023 |
| Date initiated | April 19, 2023 |
| Recalling firm | Sun Pharmaceutical Industries Ltd. |
| Firm location | Halol, N/A |
| Affected scope | 24194 Prefilled Syringes |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1. Recalled by Sun Pharmaceutical Industries Ltd.. Units affected: 24194 Prefilled Syringes.
Why was this product recalled? ▼
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0569-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0569-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported May 3, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).