CLASS II Drug recall · Reported 2 May 2018 · FDA Enforcement Report
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) recalled
Lyne Laboratories is recalling Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil). The recall was initiated on 13 Apr 2018 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-0711-2018
- FDA event ID
- 79860
- Recalling firm
- Lyne Laboratories, Brockton, MA
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2018
- FDA classified
- 4 May 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 13 Apr 2018 | Recall initiated by company | |
| 2 May 2018 | Published in enforcement report | +19 days |
| 4 May 2018 | Classified by FDA | +2 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
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043
Where it was distributed
to be entered
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: FR1603, FR1604A, Exp. 05/2018
Where was it sold?
to be entered
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 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 79860This product is part of a recall event; the main page for the event is Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) recalledFluocinolone Acetonide | Lyne Laboratories | Potency & Assay | MA | |
| CLASS II | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) recalledFluocinolone Acetonide | Lyne Laboratories | Potency & Assay | MA |
More recalls from Lyne Laboratories
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) recalledFluocinolone Acetonide | Lyne Laboratories | Potency & Assay | MA |
| Drug | CLASS II | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) recalledFluocinolone Acetonide | Lyne Laboratories | Potency & Assay | MA |
| Drug | CLASS III | Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg recalled | Lyne Laboratories | Potency & Assay | NJ |
Other Fluocinolone Acetonide recalls
All 14| 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, 0.01% (Ear Drops), package recalledFluocinolone Acetonide | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalledDermotic | Hill Dermaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution, USP, 0.01 % recalledFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide | Lupin Somerset | Potency & Assay | Nationwide |