Drug Injection Recall: Norepinephrine Bitartrate Impurity Above Specification
Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to a chemical impurity exceeding specification limits detected during routine monitoring. The recall affects 16,450 vials distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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: This is an FDA Class III recall with no reported illnesses or injuries. The impurity above specification limits represents low-risk contamination requiring precautionary action. Per the rubric, FDA Class III recalls are typically scored 1 or 2; the specification failure warrants Moderate (2) rather than Low (1).
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Norepinephrine Bitartrate Injection, USP (1 mg/mL) manufactured by Gland Pharma Limited. The recall affects 16,450 vials with lot numbers G1510001 (expiration 11/2023), G151002 (expiration 12/2023), and G151003 (expiration 02/2024), distributed nationwide.
The recall was initiated because routine product monitoring detected norepinephrine sulfonic acid impurity above specification limits. Norepinephrine Bitartrate Injection is an intravenous drug used in critical care settings to manage blood pressure.
Healthcare providers should not use the affected lots. Distributors and healthcare facilities that have received these lots should remove them from use and contact Sun Pharmaceutical for return instructions.
No illnesses or injuries have been reported in connection with this recall. The FDA classified this as a Class III recall.
The recalled product
- Product
- NOREPINEPHRINE BITARTRATE (NOREPINEPHRINE BITARTRATE)
- Brand
- NOREPINEPHRINE BITARTRATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Intravenous Injection
- Affected units
- 16,450
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 (6)
- Lot Number: G1510001
- Exp 11/2023
- G151002
- Exp. 12/2023
- and G151003
- Exp 02/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · NOREPINEPHRINE BITARTRATE
- HighIntravenous norepinephrine drug recalled for incorrect concentration labeling
FDA (Drugs) · 2024-02-28
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- HighFDA Recalls Norepinephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2023-03-08
- HighFDA Recalls NORepinephrine Injection Due to Manufacturing Violations
FDA (Drugs) · 2024-10-30
- HighNorepinephrine Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-03-08
- ModerateDrug Recall: NORepinephrine Injectable Due to Manufacturing Compliance Violations
FDA (Drugs) · 2024-10-30
- HighInjectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure
FDA (Drugs) · 2023-03-08
- HighNorepinephrine Bitartrate Injection Recalled Due to Defective Container
FDA (Drugs) · 2022-03-30