The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0654-2016·Announced 2016-02-17

Fagron Recalls SyrSpend SF Syrup Due to Yeast Contamination

Fagron, Inc. is recalling SyrSpend SF syrup-suspending vehicle due to the presence of yeast. The recall affects 44 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is microbial contamination (yeast) in a non-sterile product, with no reported illnesses or injuries mentioned in the source text.

Plain-English summary

Fagron, Inc. is recalling specific lots of SyrSpend SF, a sweetened, sugar-free syrup-suspending vehicle used for extemporaneous preparation of oral liquid dose forms. The recall is being conducted due to the presence of yeast in the product.

The affected product is identified by NDC 51552-1079-5 and is packaged in 500 mL bottles. The recall covers 44 bottles from the following lot numbers: 15I21-U01-027370, 15I21-U01-026920, and 15J19-U05-027406. The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers. If found, the product should be returned to the distributor or disposed of according to local regulations. The source text does not specify a contact number or additional instructions for consumers.

The recalled product

Product
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.
Manufacturer
Fagron, Inc
Category
Drug — Pharmaceutical Excipient
Hazard
Affected units
44

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #s: 15I21-U01-027370
  • 15I21-U01-026920
  • 15J19-U05-027406

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Fagron, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Fagron, Inc

See all →

Same hazard · microbial contamination

See all →

Similar recalls