CLASS II ONGOING Drug recall · Reported 11 Oct 2023 · FDA Enforcement Report

Dr. Berne's MSM Drops 15% Solution recalled

Dr. Berne's Whole Health Products is recalling Dr. Berne's MSM Drops 15% Solution, distributed nationwide in the US. The recall was initiated on 26 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.

Quantity recalled6060 bottles

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-0033-2024
FDA event ID: 92952
Recalling firm: Dr. Berne's Whole Health Products, Tesuque, NM
Classification: Class II
Status: Ongoing
Recall initiated: 26 Aug 2023
FDA classified: 4 Oct 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

26 Aug 2023	Recall initiated by company
4 Oct 2023	Classified by FDA	+39 days
11 Oct 2023	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, [email protected], UPC 00854582001036

Where it was distributed

Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

Nationwide

Questions about this recall

Is Dr. Berne's MSM Drops 15% Solution recalled?

Yes. Dr. Berne's Whole Health Products recalled Dr. Berne's MSM Drops 15% Solution on 26 Aug 2023. The recall is Class II and its status is Ongoing. Recall number D-0033-2024.

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lots: 6486, Exp: 11/23; 6536, Exp: 01/24; 6549, Exp: 02/24; 6561, Exp: 03/24; 6623, Exp: 06/24; 6630, Exp: 06/24; 6646, Exp: 07/24; 6675, Exp: 09/24; 6686, Exp: 09/24; 6695, Exp: 10/24; 6738, Exp: 11/24; 6767, Exp: 01/25; 6787, Exp: 03/25; 6799, Exp: 04/25; 6832 Exp: 05/25; 6844, Exp: 05/25; 6857, Exp: 06/25; 6888, Exp: 07/25.

Where was it sold?

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 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 Dr. Berne's Whole Health Products

All 5

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Drug	CLASS I	Dr. Berne's MSM Drops 5% Solution recalled	Dr. Berne's Whole Health Products	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	Dr. Berne's MSM Drops 5% Solution recalled	Dr. Berne's Whole Health Products	Manufacturing (CGMP) Deviations	Nationwide
11 Oct 2023Drug	CLASS II	Dr. Berne's MSM MIST 15% Solution recalled	Dr. Berne's Whole Health Products	Manufacturing (CGMP) Deviations	Nationwide
11 Oct 2023Drug	CLASS II	Dr. Berne's Organic Castor Oil Eye Drops recalled	Dr. Berne's Whole Health Products	Manufacturing (CGMP) Deviations	Nationwide