CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report
Dr. Berne's MSM Drops 15% Solution recalled by MSM Nutraceuticals
MSM Nutraceuticals is recalling Dr. Berne's MSM Drops 15% Solution, distributed nationwide in the US. The recall was initiated on 12 Mar 2019 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-1129-2019
- FDA event ID
- 82421
- Recalling firm
- MSM Nutraceuticals, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Mar 2019
- FDA classified
- 15 Apr 2019
- Reported
- 24 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
Timeline
| 12 Mar 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +34 days |
| 24 Apr 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Dr. Berne's MSM Drops 15% Solution recalled?
Yes. MSM Nutraceuticals recalled Dr. Berne's MSM Drops 15% Solution on 12 Mar 2019. The recall is Class II and its status is Terminated. Recall number D-1129-2019.
Why was it recalled?
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Which lots are affected?
Lot # 1808051, Exp. Date 01/01/22
Where was it sold?
Nationwide in the USA
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 MSM Nutraceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 15% MSM, Eye Drops recalled by MSM Nutraceuticals | MSM Nutraceuticals | Sterility | Nationwide |
| Drug | CLASS II | Dry Eye, Eye Drops, Active Ingredients: OptiMSM recalled | MSM Nutraceuticals | Sterility | Nationwide |
| Drug | CLASS II | Red Eye, Eye Drops, Active Ingredients: OptiMSM recalled | MSM Nutraceuticals | Sterility | Nationwide |