CLASS III Drug recall · Reported 5 May 2021 · FDA Enforcement Report
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recalled
Teligent Pharma is recalling Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), distributed nationwide in the US. The recall was initiated on 2 Feb 2021 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-0338-2021
- FDA event ID
- 87266
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Feb 2021
- FDA classified
- 23 Apr 2021
- Reported
- 5 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Feb 2021 | Recall initiated by company | |
| 23 Apr 2021 | Classified by FDA | +80 days |
| 5 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Which lots are affected?
Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
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 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.
Other products in this recall event
2 other products · FDA event 87266| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide | |
| CLASS III | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
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 Betamethasone Dipropionate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betamethasone Dipropionate Cream USP, 0.05% tube recalledBetamethasone Dipropionate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) recalled | McKesson | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |