CLASS III Drug recall · Reported 19 Apr 2017 · FDA Enforcement Report
Fluocinolone Acetonide Topical Solution USP 01% For Topical recalled
Novel Laboratories is recalling Fluocinolone Acetonide Topical Solution USP 01% For Topical Use Only, Not for Ophthalmic, distributed nationwide in the US. The recall was initiated on 22 Feb 2017 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-0653-2017
- FDA event ID
- 76231
- Recalling firm
- Novel Laboratories, Somerset, NJ
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Feb 2017
- FDA classified
- 11 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 22 Feb 2017 | Recall initiated by company | |
| 11 Apr 2017 | Classified by FDA | +48 days |
| 19 Apr 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination
Product as listed by the FDA
Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Where it was distributed
Nationwide
Questions about this recall
Is Fluocinolone Acetonide Topical Solution USP 01% For Topical Use Only, Not for Ophthalmic recalled?
Yes. Novel Laboratories recalled Fluocinolone Acetonide Topical Solution USP 01% For Topical Use Only, Not for Ophthalmic on 22 Feb 2017. The recall is Class III and its status is Terminated. Recall number D-0653-2017.
Why was it recalled?
Chemical Contamination
Which lots are affected?
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
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 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.
More recalls from Novel Laboratories
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|---|---|---|---|---|---|
| Drug | CLASS III | Lupin Hydrocodone Bitartrate recalled by Novel LaboratoriesHydrocodone Bitartrate And Homatropine Methylbromide | Novel Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Famotidine for Oral Suspension, USP 40 mg recalled by Novel LaboratoriesFamotidine | Novel Laboratories | Potency & Assay | Nationwide |
Other Fluocinolone Acetonide recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Oil, 01% (Ear Drops), package in fill volume) recalledFluocinolone Acetonide | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS II | DermOtic Oil (fluocinolone acetonide oil) 01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution, USP, 01 % recalledFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |