CLASS II ONGOING Drug recall · Reported 11 May 2022 · FDA Enforcement Report
Betamethasone Dipropionate Ointment USP, 05%* (Augmented) recalled
McKesson is recalling Betamethasone Dipropionate Ointment USP, 05%* (Augmented) (Potency expressed as, distributed nationwide in the US. The recall was initiated on 21 Apr 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-0850-2022
- FDA event ID
- 89986
- Recalling firm
- McKesson, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Apr 2022
- FDA classified
- 5 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 21 Apr 2022 | Recall initiated by company | |
| 5 May 2022 | Classified by FDA | +14 days |
| 11 May 2022 | Published in enforcement report | +6 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 manufacturing firm, Teligent Pharma, Inc.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
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65
Where it was distributed
Nationwide in the United States including Guam and the Northern Mariana Islands.
Questions about this recall
Is Betamethasone Dipropionate Ointment USP, 05%* (Augmented) (Potency expressed as recalled?
Yes. McKesson recalled Betamethasone Dipropionate Ointment USP, 05%* (Augmented) (Potency expressed as on 21 Apr 2022. The recall is Class II and its status is Ongoing. Recall number D-0850-2022.
Why was it recalled?
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Which lots are affected?
Lot: 15644, Exp.: 05/31/2022
Where was it sold?
Nationwide in the United States including Guam and the Northern Mariana Islands.
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.
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Other Betamethasone dipropionate recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betamethasone Dipropionate Cream USP, 05% tube recalledBetamethasone Dipropionate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 05%* (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP, 05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Betamethasone Dipropionate Lotion USP (Augmented) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Betamethasone Dipropionate Ointment USP, 05% (Augmented) recalled | Teligent Pharma | Potency & Assay | Nationwide |