LETS GEL KIT (Fagron) – Microbial Contamination (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1
Brand
Fagron, Inc
Lot Codes / Batch Numbers
Lot, expiry: 18F25-U03-044296, 11/8/2019, 18F25-U04-044297, 11/8/2019, 18H22-U06-045284, 1/24/2020, 18I24-U05-045853, 11/8/2019, 18K06-U03-047041, 1/24/2020, 18K06-U04-047042, 1/24/2020, 18K27-U11-047460, 3/16/2020, 18K28-U10-047519, 3/16/2020, 19A06-U02-048182, 3/16/2020, 19A06-U03-048183, 3/16/2020, 19A16-U13-048363, 3/16/2020, 19A21-U02-048503, 3/16/2020, 19B10-U02-048787, 3/16/2020, 19B14-U05-048781, 3/16/2020, 19C05-U01-049199, 3/16/2020, 19C05-U02-049200, 3/16/2020, 19C11-U07-049451, 3/16/2020 19C25-U02-048758, 3/16/2020, 19D07-U01-049884, 3/16/2020, 19D07-U02-049885, 3/16/2020, 19E09-U01-050298, 3/16/2020, 19E23-U01-050763, 9/11/2020, 19F16-U12-000052, 9/11/2020, 19F16-U13-000053, 10/24/2020, 19G07-U01-000357, 10/24/2020, 19G07-U02-000358, 10/24/2020, 19G21-U01-000930, 10/24/2020, 19G21-U02-000931, 12/17/2020, 19H01-U01-001172, 12/17/2020, 19H01-U02-001174, 12/17/2020, 19I03-U01-002019, 2/4/2021, 19I03-U02-002020, 2/4/2021, 19I03-U03-002021, 12/17/2020
Products Sold
Lot, expiry: 18F25-U03-044296, 11/8/2019; 18F25-U04-044297, 11/8/2019; 18H22-U06-045284, 1/24/2020; 18I24-U05-045853, 11/8/2019; 18K06-U03-047041, 1/24/2020; 18K06-U04-047042, 1/24/2020; 18K27-U11-047460, 3/16/2020; 18K28-U10-047519, 3/16/2020; 19A06-U02-048182, 3/16/2020; 19A06-U03-048183, 3/16/2020; 19A16-U13-048363, 3/16/2020; 19A21-U02-048503, 3/16/2020; 19B10-U02-048787, 3/16/2020; 19B14-U05-048781, 3/16/2020; 19C05-U01-049199, 3/16/2020; 19C05-U02-049200, 3/16/2020; 19C11-U07-049451, 3/16/2020 19C25-U02-048758, 3/16/2020; 19D07-U01-049884, 3/16/2020; 19D07-U02-049885, 3/16/2020; 19E09-U01-050298, 3/16/2020; 19E23-U01-050763, 9/11/2020; 19F16-U12-000052, 9/11/2020; 19F16-U13-000053, 10/24/2020; 19G07-U01-000357, 10/24/2020; 19G07-U02-000358, 10/24/2020; 19G21-U01-000930, 10/24/2020; 19G21-U02-000931, 12/17/2020; 19H01-U01-001172, 12/17/2020; 19H01-U02-001174, 12/17/2020; 19I03-U01-002019, 2/4/2021; 19I03-U02-002020, 2/4/2021; 19I03-U03-002021, 12/17/2020
Fagron, Inc is recalling LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocai due to Microbial contamination of non-sterile product.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial contamination of non-sterile product.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026