CLASS III Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Mometasone Furoate Cream, 0.1% tube recalled by ACP Nimble Buyer
ACP Nimble Buyer is recalling Mometasone Furoate Cream, 0.1% tube, distributed nationwide in the US. The recall was initiated on 7 Feb 2019 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-0514-2019
- FDA event ID
- 80878
- Recalling firm
- ACP Nimble Buyer, South Plainfield, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Feb 2019
- FDA classified
- 20 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Classified by FDA | +13 days |
| 27 Feb 2019 | 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
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Product as listed by the FDA
Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Which lots are affected?
Lot #: 1009431, 1009507, Exp. 08/2020; 1009886, Exp. 09/2020
Where was it sold?
Nationwide within the United States
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 |