CLASS III Drug recall · Reported 9 Dec 2020 · FDA Enforcement Report
Clobetasol Propionate Ointment recalled by Teligent Pharma
Teligent Pharma is recalling Clobetasol Propionate Ointment USP 0.05%, distributed nationwide in the US. The recall was initiated on 5 Nov 2020 and the FDA has classified it as Class III.
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-0119-2021
- FDA event ID
- 86714
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Nov 2020
- FDA classified
- 8 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 5 Nov 2020 | Recall initiated by company | |
| 8 Dec 2020 | Classified by FDA | +33 days |
| 9 Dec 2020 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent and Subpotent; low and high assay results
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
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent and Subpotent; low and high assay results
Which lots are affected?
Lot Number: 12597, exp. date 12/2020
Where was it sold?
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
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|---|---|---|---|---|---|
| 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 Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Cream recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled | Preferred Pharmaceuticals | Potency & Assay | IL |