CLASS III Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report
Mometasone Furoate Ointment USP, 0.1% tubes recalled
Perrigo Israel Pharmaceuticals is recalling Mometasone Furoate Ointment USP, 0.1% tubes, distributed nationwide in the US. The recall was initiated on 13 Jul 2015 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-1286-2015
- FDA event ID
- 71765
- Recalling firm
- Perrigo Israel Pharmaceuticals, Yeruham, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Jul 2015
- FDA classified
- 5 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Jul 2015 | Recall initiated by company | |
| 5 Aug 2015 | Classified by FDA | +23 days |
| 12 Aug 2015 | 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
Subpotent drug
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
Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent drug
Which lots are affected?
Lot # 063630, Exp 04/16; 069793, Exp 11/16; 071745, Exp 02/17; 076150, Exp 07/17; 081317, Exp 12/17
Where was it sold?
Nationwide 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 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 Mometasone Furoate recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
| Drug | CLASS II | Asmanex Twisthaler (mometasone furoate inhalation powder recalledAsmanex | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant recalledSinuva | Intersect ENT | Potency & Assay | Nationwide |
| Drug | CLASS III | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle recalledMometasone Furoate | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |