CLASS II Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Gentamicin Sulfate Cream recalled by Teligent Pharma
Teligent Pharma is recalling Gentamicin Sulfate Cream USP, 1%, distributed nationwide in the US. The recall was initiated on 15 Mar 2022 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-0686-2022
- FDA event ID
- 89798
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2022
- FDA classified
- 21 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Mar 2022 | Recall initiated by company | |
| 21 Mar 2022 | Classified by FDA | +6 days |
| 30 Mar 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Gentamicin Sulfate Cream USP, 1% recalled?
Yes. Teligent Pharma recalled Gentamicin Sulfate Cream USP, 1% on 15 Mar 2022. The recall is Class II and its status is Terminated. Recall number D-0686-2022.
Why was it recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which lots are affected?
Batch: a) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022
Where was it sold?
Nationwide in the USA and Puerto Rico
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 21 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 Gentamicin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gentamicin Injection, USP, (Pediatric), 20 mg recalled by Eugia USGentamicin | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Ointment USP 1%, packaged as a) tube recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Gentamicin Injection, USP, equivalent to 40 mg/mL recalledGentamicin | Fresenius Kabi USA | Other | Nationwide |
| Drug | CLASS II | Gentamicin Sulfate Injection USP 80 mg/(40 mg/mL as recalled by HospiraGentamicin Sulfate | Hospira | Particulate Matter | Nationwide |