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American Regent: Multiple Packaged In Injections
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DRUG RECALLCRITICAL

American Regent: Multiple Packaged In Injections

American Regent recalls Nitroglycerin Injection 50 mg/10 mL and other injectables due to particulate matter (hair).

What to do

Stop using the recalled products immediately. Return them to the place of purchase or discard them. Contact American Regent, Inc. for further instructions.

Recalled
Updated
Recall No.
D-0794-2026
Agency
FDA
Firm
American Regent, Inc.
Recall ID
99503
Status
ONGOING

Why it was recalled

American Regent is recalling Nitroglycerin Injection, USP, 50 mg/10 mL (5 mg/mL), packaged in 10 mL vials, due to the presence of particulate matter identified as hair. The recall also covers multiple other injectable products from the same manufacturer. Healthcare facilities and distributors should stop using the affected products and return them to the place of purchase or discard them.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

American Regent, Inc. Papaverine Hydrochloride Injection, USP, 60 mg 2 mL

Lot code
25202
Best-by
11/30/2026
NDC
0517-4002-25

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification