Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mafenide Acetate Recalled by Par Pharmaceutical Inc. Due to Presence of Foreign Substance; oxidized steel, organic material...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Par Pharmaceutical Inc. directly.
Affected Products
Mafenide Acetate, USP, For 5% Topical Solution, STERILE, Net Wt. 50 grams sterile powder per packet, Rx only, PAR Pharmaceuticals label --- Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Made in India -- NDC 49884-902-52 (packets of 50 g) and NDC 49884-902-78 (cartons of five 50 g packets)
Quantity: 2856 cartons (each containing 5 packets)
Why Was This Recalled?
Presence of Foreign Substance; oxidized steel, organic material and shredded polypropylene
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Par Pharmaceutical Inc.
Par Pharmaceutical Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report