CLASS I Drug recall · Reported 18 May 2022 · FDA Enforcement Report
SyrSpend SF Suspending Base, Cherry Flavored recalled by Fagron
Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored, distributed nationwide in the US. The recall was initiated on 4 Mar 2022 and the FDA has classified it as Class I.
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
Timeline
| 4 Mar 2022 | Recall initiated by company | |
| 9 May 2022 | Classified by FDA | +66 days |
| 18 May 2022 | Published in enforcement report | +9 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 Product: Product is contaminated with Burkholderia gladioli.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Where it was distributed
Nationwide USA and Puerto Rico, Canada, Columbia, France
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Which lots are affected?
Lot #: a) A67185, Exp. Date 08/31/2024; b) Lot #: A67186, Exp. Date 08/31/2024
Where was it sold?
Nationwide USA and Puerto Rico, Canada, Columbia, France
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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 |
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