Downing Labs Recalls Ascorbic Acid Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL vials due to a lack of assurance of sterility. The recall affects 4,857 vials distributed in the US and 17 other countries.
What this means for you
Illness, injury, or structural failure has been reported. 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 severity rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in injectables) corresponds to a score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but involves a significant risk of harm.
Plain-English summary
Downing Labs, LLC is recalling Ascorbic Acid Injectable 500mg/mL, packaged in 10mL, 50mL, and 100mL vials. The recall is being conducted due to a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide in the United States as well as in 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 involves 4,857 vials across all lots. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. Downing Labs, LLC can be reached at 1-800-914-7435 for additional information regarding the recall.
The recalled product
- Product
- Ascorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, 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
- 4,857
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 →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29