FDA Class I Recall: DOXORUBICIN HYDROCHLORIDE by SUN PHARMACEUTICAL INDUSTRIES INC

Key facts

What consumers should do

Because FDA has assigned this recall its highest severity classification, anyone who has this product should stop using it immediately, regardless of whether a problem has been noticed yet. Specifically, check whether the product in your possession matches the description on file with FDA -- DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. -- and the recall number D-0580-2026. If it matches, stop using or distributing it and contact SUN PHARMACEUTICAL INDUSTRIES INC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class I when there is a reasonable probability that using the recalled product, or being exposed to it, will cause serious adverse health consequences or death. Class I is FDA's most serious recall classification. In this case, the recalling firm is SUN PHARMACEUTICAL INDUSTRIES INC and the affected product is described in FDA's record as: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.. FDA's stated reason for the recall is: Presence of Particulate matter: Particulate matter identified as glass.. The recall is tracked under FDA recall number D-0580-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

SUN PHARMACEUTICAL INDUSTRIES INC’s FDA history

Argus HQ has recorded 8 total FDA actions tied to SUN PHARMACEUTICAL INDUSTRIES INC: 0 warning letters, 8 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has SUN PHARMACEUTICAL INDUSTRIES INC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 8 total FDA actions tied to SUN PHARMACEUTICAL INDUSTRIES INC, including 8 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0580-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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