CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Tesamorelin, 1mg/vial, Lyophilized Powder recalled
Tailor Made Compounding is recalling Tesamorelin, 1mg/vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, distributed nationwide in the US. The recall was initiated on 28 Sep 2018 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-0223-2019
- FDA event ID
- 81337
- Recalling firm
- Tailor Made Compounding, Nicholasville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2018
- FDA classified
- 7 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Sep 2018 | Recall initiated by company | |
| 7 Nov 2018 | Classified by FDA | +40 days |
| 14 Nov 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Product as listed by the FDA
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Which lots are affected?
Lot, exp: 7101804, 7111807, 7131807, 7151801, 7161804, 7181805, 7191801, 7201803, 7211801, 7221801, 7231805, 7241803, 7251803, 7261802, 7271801, 7281801, 7301805, 7311805, exp 7/19; 8021801, 8031801, 8041801, 8081802, 8091804, 8101803, 8111810, 8121801, 8141801, 8161803, 8171803, 8201801, 8251801, exp 8/19
Where was it sold?
Nationwide USA
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Tesamorelin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tesamorelin for Injection, 15mg Multi-Dose Vial, GenoGenix recalled | GenoGenix | Sterility | Nationwide |