Downing Labs Recalls DMSO 99% Injection Due to Sterility Concerns
Downing Labs, LLC is recalling DMSO 99% Injection vials because the product lacks assurance of sterility. The recall affects 187 vials distributed in the US and internationally.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product is rated as Severe (4).
Plain-English summary
Downing Labs, LLC is recalling 187 vials of DMSO 99% Injection, 50mL vial, Rx only. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the US and in several international locations, including Australia, Brazil, the Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, the Philippines, Singapore, Thailand, Trinidad and Tobago, and Taiwan.
The recall covers all lots of the product. Consumers and healthcare providers should stop using the recalled product and contact Downing Labs, LLC at 1-800-914-7435 for further instructions.
The recalled product
- Product
- DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
- Manufacturer
- Downing Labs, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 187
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 48 recalled by Downing Labs, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 48 products in this recall →Related recalls
Same manufacturer · Downing Labs, LLC
See all →- SevereDowning Labs Recalls L-Glutathione Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls HCG Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls Chromium Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls L-Arginine Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls EDTA Disodium Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereGreen Valley Drugs Recalls DMSO Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SevereKey Pharmacy Recalls DMPS Acid Injections Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- SevereAdvanced Physician Solutions Recalls DMSO Injectable Vials Due to Sterility Concerns
FDA (Drugs) · 2015-06-03
- SevereBeacon Hill Medical Pharmacy Recalls DMSO 50% Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18
- SevereMedaus Recalls DMSO 99.9 Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- HighFDA Recalls Vital Care Compounder DMSO and Lidocaine Vials for Sterility Concerns
FDA (Drugs) · 2016-10-05