Lyne Laboratories Recalls Fluocinolone Scalp Oil Due to Subpotent Drug Risk
Lyne Laboratories recalls 0.01% Fluocinolone Acetonide Topical Oil (Scalp Oil) 4 fl.oz. Rx only due to subpotent drug levels. This may not provide intended treatment for scalp conditions.
Lower-risk recall
Subpotent Drug
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What happened, in plain English
Lyne Laboratories is recalling a 4 fl.oz. scalp oil medication that may not contain enough active ingredient to treat scalp conditions. This subpotent drug risk means the product might not work as intended for people using it under a doctor's prescription. Read more at govinfonow.com/recall/40612-lyne-laboratories-recalls-fluocinolone-scalp-oil-due-to-subpotent-drug.
Source Summary by GovInfoNow · govinfonow.com/recall/40612-lyne-laboratories-recalls-fluocinolone-scalp-oil-due-to-subpotent-drug · Updated October 7, 2026 · FDA enforcement record: FDA #D-0713-2018
Cite this page
“Lyne Laboratories Recalls Fluocinolone Scalp Oil Due to Subpotent Drug Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40612-lyne-laboratories-recalls-fluocinolone-scalp-oil-due-to-subpotent-drug. Based on FDA recall #D-0713-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0713-2018%22&limit=1).
Why it’s dangerous
The product contains less active drug than intended, so it may not effectively treat scalp conditions. This subpotent drug risk means the medication might not work as prescribed by a doctor.
Who’s affected
People with a prescription for this scalp oil medication from Lyne Laboratories. Those with scalp conditions requiring treatment are most at risk.
How to tell if you have this one
Check for the product name 'Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only'. Look for lot numbers FR1601 or FR1602 and expiration date 05/2018.
- Brand
Lyne Laboratories- Product
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
to be entered
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0711-2018 | 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; Lot #: FR1603, FR1604A, Exp. 05/2018 | 12572 units | 64980-331-04, 3649803310 |
| D-0712-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200; Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018 | 17939 units | 64980-329-20, 3649803292 |
| D-0713-2018 | Fluocinolone Acetonide Topical Oil, 0.01% (Scalp 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 64980-330-04, UPC 364980330046; Lot #: FR1601, FR1602, Exp. 05/2018 | 23453 units | 64980-330-04, 3649803300 |
What to do — step by step
Check Product Details
Look for lot numbers FR1601 or FR1602 and expiration date 05/2018 on the product label.
How this recall unfolded
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0713-2018 (April 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0713-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.