Home / Recalls / ULTRAtab Laboratories, Inc. / D-0535-2022

D-0535-2022 Class II Terminated

Recalled by ULTRAtab Laboratories, Inc. — Highland, NY

FDA drug recall D-0535-2022 was initiated by ULTRAtab Laboratories, Inc. on Jan 26, 2022 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Jan 7, 2025). Affected quantity: 6,215,512 tablets.

Recall Details

Product Type
Drugs
Report Date
Feb 16, 2022
Initiation Date
Jan 26, 2022
Termination Date
Jan 7, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,215,512 tablets

Product Description

Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00

Reason for Recall

CGMP Deviations

Distribution Pattern

Bulk product was distributed to 3 distributors who may have distributed finished product.

Code Information

Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0535-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by ULTRAtab Laboratories, Inc.

  • D-0552-2022 Class II — Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container… (Jan 26, 2022)
  • D-0530-2022 Class II — APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg)… (Jan 26, 2022)
  • D-0533-2022 Class II — Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories… (Jan 26, 2022)
  • D-0540-2022 Class II — Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab… (Jan 26, 2022)
  • D-0534-2022 Class II — Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab… (Jan 26, 2022)
  • D-0532-2022 Class II — Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories… (Jan 26, 2022)
  • D-0542-2022 Class II — Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab… (Jan 26, 2022)
  • D-0550-2022 Class II — Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container… (Jan 26, 2022)
  • D-0545-2022 Class II — Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab… (Jan 26, 2022)
  • D-0529-2022 Class II — APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab… (Jan 26, 2022)

FDA data resources