Use caution Drug recall · FDA · Published March 29, 2023

Sun Pharma Recalls Norepinephrine Injections Due to Impurities

Sun Pharmaceutical recalls specific lots of Norepinephrine Bitartrate Injection due to failed impurity specifications. Check your lot numbers immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0529-2023Drug Sun Pharmaceutical ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Take action

Contact the company

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC2 Independence Way · Princeton, NJ 08540-6620

✎ GovInfoNow plain-language explainer

Sun Pharmaceutical Industries Inc. is recalling specific lots of Norepinephrine Bitartrate Injection, USP because the product contains above-specification levels of a related substance impurity called norepinephrine sulfonic acid. The recall affects 16,450 vials distributed nationwide in the USA. This issue was identified during routine product monitoring. Read more at govinfonow.com/recall/33749-sun-pharma-recalls-norepinephrine-injections-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/33749-sun-pharma-recalls-norepinephrine-injections-due-to-impurities · Updated October 10, 2026 · FDA enforcement record: FDA #D-0529-2023

Cite this page

“Sun Pharma Recalls Norepinephrine Injections Due to Impurities.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/33749-sun-pharma-recalls-norepinephrine-injections-due-to-impurities. Based on FDA recall #D-0529-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0529-2023%22&limit=1).

The FDA announced on March 29, 2023, that Sun Pharmaceutical is recalling Norepinephrine Bitartrate Injection due to failed impurity specifications. The agency stated the recall involves 16,450 vials distributed nationwide.

How to tell if you have it

Brand: Sun Pharmaceutical
Product: Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial
NDC: 47335-615-40 and 47335-615-44
Lot Numbers: G1510001 (Exp 11/2023), G151002 (Exp. 12/2023), and G151003 (Exp 02/2024)
Quantity: 16,450 vials

The hazard

According to the FDA, the recalled product contains above-specification limits of the related substance norepinephrine sulfonic acid impurity. This failure occurred during routine product monitoring.

Context

GovInfoNow's records show SUN PHARMACEUTICAL INDUSTRIES INC has 93 other recalls on record since May 21, 2013. Other recent recalls of similar products include Sun Pharmaceutical Nystatin Cream Recall (Sept. 14, 2026) and Sun Pharmaceutical Carbamazepine Tablets Recall (Aug. 3, 2026). Additional recent actions involve Somerset Therapeutics Dexamethasone Injection Recall (Feb. 4, 2026), SUN PHARMA Ciclopirox Shampoo 1% Recall (Dec. 9, 2025), and Sagent Busulfan Injection Recall (May 4, 2026).

How to tell if you have this one

Look for Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL (1 mg/mL), in 4 mL Single-dose Fliptop Vials. Check the carton for NDC 47335-615-44 and verify the lot number against: G1510001 (Exp 11/2023), G151002 (Exp 12/2023), or G151003 (Exp 02/2024).

Brand
Sun Pharmaceutical
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your vials match the recalled lot numbers: G1510001, G151002, or G151003.
Contact Healthcare Provider
If you have these lots, consult your healthcare provider for guidance on disposal or replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Mar 29, 2023Firm started the recall
Apr 10, 2023FDA classified it Class III
Apr 19, 2023Published in FDA’s Enforcement Report
Oct 31, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Sun Pharmaceutical recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33749-sun-pharma-recalls-norepinephrine-injections-due-to-impurities">Sun Pharma Recalls Norepinephrine Injections Due to Impurities (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0529-2023 (March 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0529-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.