Atlas Pharmaceuticals Recalls Ascorbic Acid Injection Due to Corn Source Labeling Error
Atlas Pharmaceuticals is recalling Ascorbic Acid Sterile Injection Solution vials labeled as 'Non-Corn Source' but actually derived from corn. The recall affects 1,646 vials distributed to healthcare facilities in Arizona and Colorado.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding the corn source of the product. No illnesses or injuries are reported in the source text, and the hazard is limited to mislabeling, which aligns with the 'Moderate' severity criteria for minor labeling errors.
Plain-English summary
Atlas Pharmaceuticals, LLC is recalling 1,646 vials of Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial. The product is labeled as 'Non-Corn Source,' but the source text indicates the product is actually from a corn source. This labeling discrepancy is the reason for the recall.
The affected product is identified by NDC 71591-500-50. Specific lot numbers and best-use dates involved in the recall include S-60162 (BUD 10/12/2019), S-60176 (BUD 11/2/2019), S-60187 (BUD 11/11/2019), S-60189 (BUD 11/16/2019), S-60190 (BUD 11/16/2019), and S-60222 (BUD 01/20/2020). The product was distributed to healthcare facilities and clinics in Arizona and Colorado.
The FDA has classified this recall as Class II. Healthcare facilities and clinics in the affected states should verify their inventory against the listed lot numbers and discontinue use of the affected vials. Patients who have received this product should consult their healthcare provider if they have concerns regarding corn sensitivity or other related issues.
The recalled product
- Product
- Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50.
- Manufacturer
- Atlas Pharmaceuticals, LLC
- Category
- Drug — Injectable Solution
- Affected units
- 1,646
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 (11)
- Lot #: S-60162
- BUD 10/12/2019
- S-60176
- BUD 11/2/2019
- S-60187
- BUD 11/11/2019
- S-60189
- BUD 11/16/2019
- S-60190
- S-60222
- BUD 01/20/2020
Distribution
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