Medisca Recalls L-Citrulline API Due to Labeling Error
Medisca Inc is recalling L-Citrulline API bottles because FDA testing found the product contained N-acetyl-leucine instead of the labeled ingredient.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Medisca Inc is recalling specific bottles of L-Citrulline API (Active Pharmaceutical Ingredient) due to a labeling error. The affected products are white crystals or crystalline powder packaged in 25 g, 100 g, 500 g, and 1 kg plastic bottles. The recall covers specific lot numbers with an expiration date of 10/31/2014.
The FDA tested samples of the API labeled as L-Citrulline and found that no L-Citrulline was present. Instead, the samples contained N-acetyl-leucine. This constitutes a label mix-up where the actual chemical content did not match the product label.
The affected products were distributed nationwide and in Australia. The products are intended for use in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations. Consumers and healthcare professionals should stop using the affected lots and contact Medisca Inc for instructions on return or disposal.
The recalled product
- Product
- CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by M
- Manufacturer
- Medisca Inc
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 (9)
- Lot #s: 95482/A
- 95482/B
- 95482/C
- 95482/D
- 96453/A
- 96453/B
- 96453/C
- and 96453/D
- Exp. 10/31/2014
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medisca Inc
See all →- ModerateBimatoprost Bulk Powder Recalled by Medisca for CGMP Deviations
FDA (Drugs) · 2025-04-30
- HighBudesonide USP drug ingredient recalled for glass contamination
FDA (Drugs) · 2024-07-10
- SevereMedisca Recalls Estriol USP Micronized Due to Failed Impurity Specifications
FDA (Drugs) · 2019-12-25
- ModerateMedisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations
FDA (Drugs) · 2017-09-27
- SevereMedisca Recalls Estrone USP Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02