Lyne Laboratories Fluocinolone Acetonide Topical Oil Recall

Why it was recalled

Subpotent Drug

Product description

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 numbers, UPCs & expiration codes

Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018

Where it was sold

to be entered

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0712-2018
Classification: Class II
Status: Terminated
Recall initiated: Apr 13, 2018
FDA report date: May 2, 2018
Quantity: 17939 units
Recall type: Voluntary: Firm initiated
Recalling firm: Lyne Laboratories, Inc.

Original FDA data

Every field from FDA enforcement report D-0712-2018, exactly as published.

Show all FDA fields

City: Brockton
State: MA
Status: Terminated
Country: United States
Event ID: 79860
Address: 10 Burke Dr
Code information: Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018
Postal code: 02301-5505
Report date: May 2, 2018
Product type: Drugs
Recall number: D-0712-2018
Classification: Class II
Recalling firm: Lyne Laboratories, Inc.
Product quantity: 17939 units
Termination date: May 16, 2019
Reason for recall: Subpotent Drug
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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
Distribution pattern: to be entered
Recall initiation date: Apr 13, 2018
Initial firm notification: Letter
Center classification date: May 4, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0712-2018, published May 2, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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