The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0702-2022·Announced 2022-03-30

Gentamicin Sulfate Cream Recalled Due to Manufacturing Practice Violations

Teligent Pharma, Inc. is recalling 31,489 tubes of Gentamicin Sulfate Cream (0.1%) nationwide due to manufacturing violations. The company discontinued its stability testing program without proper authorization.

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: FDA Class II recall with no reported illnesses or injuries. The hazard—discontinuation of required stability testing—is a manufacturing compliance issue rather than a confirmed product contamination or defect. This type of voluntary precautionary recall based on process deviations is classified as Moderate.

Plain-English summary

Teligent Pharma, Inc. has recalled Gentamicin Sulfate Cream USP 0.1% (NDC 70512-036-30), a prescription topical antibiotic manufactured for SOLA Pharmaceuticals, LLC, due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, which is required to ensure the product remains safe and effective throughout its shelf life.

The recall affects approximately 31,489 tubes distributed nationwide in the United States and Puerto Rico. The affected batches are Batch 15725 (expiration 6/30/2022) and Batch 16113 (expiration 10/31/2022). All products within their expiration dates are being recalled.

The recalled product

Product
Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Antibiotic
Hazard
Affected units
31,489

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 (4)

  • Batch: 15725
  • Exp. 6/30/2022
  • 16113
  • Exp. 10/31/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, 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 37 products in this recall →

Related recalls

Same manufacturer · Teligent Pharma, Inc.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls