Class II U.S. Food and Drug Administration

Blaine Labs Inc Revitaderm Wound Care, First Aid Antiseptic Gel recall: CGMP Deviations; product manufactured in the same facility under the same

Recall published 4 months ago

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0699-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Blaine Labs Inc
Product type
Prescription & OTC drugs
Units affected
5,555 bottles and tubes
Distribution
Nationwide
Made in
United States
Lot / code info
Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27

Products covered by this recall

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • BL3435
  • 11
  • 06
  • 26

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 06
  • 26
  • 08
  • 07
  • 27

NDC number

On the carton and again on the bottle or blister label.

  • 63347-120-02
  • 63347-120-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 1.0 Fl OZ
  • 16 mL
  • 3.0 Fl OZ
  • 1 oz
  • 3 oz

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Blaine Labs Inc — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  3. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  4. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Blaine Labs Inc — 11037 Lockport Pl, Santa Fe Springs, CA, 90670-4634

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Blaine Labs Inc prescription & otc drugs recalled?

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code BL3435, 11, 06; best-by date 11 or 06. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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