CLASS II Drug recall · Reported 9 Mar 2016 · FDA Enforcement Report
Thyrogen (thyrotropin alfa for injection) recalled by Genzyme
Genzyme is recalling Thyrogen (thyrotropin alfa for injection), 9 mg/mL after reconstitution, For, distributed nationwide in the US. The recall was initiated on 16 Feb 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0729-2016
- FDA event ID
- 73301
- Recalling firm
- Genzyme, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Feb 2016
- FDA classified
- 26 Feb 2016
- Reported
- 9 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Feb 2016 | Recall initiated by company | |
| 26 Feb 2016 | Classified by FDA | +10 days |
| 9 Mar 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Product as listed by the FDA
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
Where it was distributed
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Questions about this recall
Is Thyrogen (thyrotropin alfa for injection), 9 mg/mL after reconstitution, For recalled?
Yes. Genzyme recalled Thyrogen (thyrotropin alfa for injection), 9 mg/mL after reconstitution, For on 16 Feb 2016. The recall is Class II and its status is Terminated. Recall number D-0729-2016.
Why was it recalled?
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Which lots are affected?
Lot #: E4029Y02 (carton), E4029 (vial) Exp 09/2016
Where was it sold?
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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