The Recall Desk
ModerateFDA (Drugs)·D-0689-2021·Announced 2021-07-28

Erythromycin Topical Solution 2% Recalled for Failed Impurities Specifications

Teligent Pharma, Inc. is recalling Erythromycin Topical Solution USP 2% (60 mL, Lot 14180) distributed nationwide because it failed impurities and degradation specifications.

What this means for you

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: This is an FDA Class III recall involving failed manufacturing specifications (impurities/degradation) with no reported illnesses or injuries stated in the source. This represents a precautionary recall concern rather than a demonstrated safety crisis, consistent with Class III drug recalls.

Plain-English summary

Teligent Pharma, Inc. is recalling 7,872 tubes of Erythromycin Topical Solution USP, 2% (60 mL, NDC 52565-027-59, Lot 14180) because the product failed impurities and degradation specifications.

The affected product was distributed nationwide. Consumers who have received this medication should contact their pharmacist or healthcare provider for guidance. Patients should not stop using the medication without consulting their healthcare provider, as this is a prescription product and any changes to therapy should be medically supervised.

The recalled product

Product
Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Manufacturer
Teligent Pharma, Inc.
Hazard
  • failed-specifications
  • impurities
  • degradation

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 (1)

  • Lot 14180

Distribution

Distributed nationwide across the United States.