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Class II · ModerateRecall completed

HPC Tablet (Acetaminophen 110 mg

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberProduct Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040
Where it was soldBulk product was distributed to 3 distributors who may have distributed finished product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forULTRAtab Laboratories, Inc.
NDC62969-242-00
Show the full FDA record
Full product labelHPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Recalling firmULTRAtab Laboratories, Inc.
DistributionBulk product was distributed to 3 distributors who may have distributed finished product.
Quantity50,585,623 tablets
Recall initiated2022-01-26
Report date2022-02-16
Recall completed2025-01-07
Recall numberD-0538-2022
ClassificationClass II
FDA statusTerminated
Origin on fileHighland NY United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.