CLASS II ONGOING Drug recall · Reported 1 Sep 2021 · FDA Enforcement Report
Erythromycin Topical Solution recalled by Teligent Pharma
Teligent Pharma is recalling Erythromycin Topical Solution USP, 2%, distributed nationwide in the US. The recall was initiated on 29 Jul 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0769-2021
- FDA event ID
- 88377
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2021
- FDA classified
- 25 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 29 Jul 2021 | Recall initiated by company | |
| 25 Aug 2021 | Classified by FDA | +27 days |
| 1 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: possibility for lack of seal integrity.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Defective container: possibility for lack of seal integrity.
Which lots are affected?
Lot #: 14892, Exp 1/2022
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teligent Pharma
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Econazole Nitrate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Topical Solution recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
Other Erythromycin recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Ophthalmic Ointment recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Erythromycin Ophthalmic Ointment recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Erythromycin Topical Gel recalled by McKesson | McKesson | Potency & Assay | Nationwide |