CLASS II Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report
SyrSpend SF, a convenient, sweetened recalled by Fagron
Fagron is recalling SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially, distributed nationwide in the US. The recall was initiated on 11 Nov 2015 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-0654-2016
- FDA event ID
- 72886
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Nov 2015
- FDA classified
- 5 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Mold
Timeline
| 11 Nov 2015 | Recall initiated by company | |
| 5 Feb 2016 | Classified by FDA | +86 days |
| 17 Feb 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
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Product as listed by the FDA
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
Which lots are affected?
Lot #s: 15I21-U01-027370; 15I21-U01-026920; 15J19-U05-027406
Where was it sold?
Nationwide
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 products in this recall event
2 other products · FDA event 72886| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | SyrSpend SF, Suspending Base, a convenient, sweetened recalled by Fagron | Fagron | Mold | Nationwide | |
| CLASS II | SyrSpend SF, Suspending Base, Grape Flavored, a convenient recalled | Fagron | Mold | Nationwide |
More recalls from Fagron
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin 150 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 500 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |
Other Syrspend Sf recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | SyrSpend SF, Suspending Base, a convenient, sweetened recalled by Fagron | Fagron | Mold | Nationwide |