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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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.
- Category
- Drug — Topical Antibiotic
- Affected units
- 7,872
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.
Part of a larger recall action
This product is one of 2 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.
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