Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg Recalled by ULTRAtab Laboratories, Inc. Due to CGMP Deviations
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 ULTRAtab Laboratories, Inc. directly.
Affected Products
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Quantity: 14,566,510 tablets
Why Was This Recalled?
CGMP Deviations
Where Was This Sold?
Bulk product was distributed to 3 distributors who may have distributed finished product.
About ULTRAtab Laboratories, Inc.
ULTRAtab Laboratories, Inc. has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report