ULTRAtab Laboratories, Inc.

Complete recall history across all FDA and CPSC categories — 43 total recalls

ULTRAtab Laboratories, Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (34)

FDA drug safety enforcement actions by ULTRAtab Laboratories, Inc.

Date Product Reason Class
Jan 26, 2022 Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Conta... CGMP Deviations Class II
Jan 26, 2022 APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg... CGMP Deviations Class II
Jan 26, 2022 APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Labora... CGMP Deviations Class II
Jan 26, 2022 APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laborator... CGMP Deviations Class II
Jan 26, 2022 Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratori... CGMP Deviations Class II
Jan 26, 2022 Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) ... CGMP Deviations Class II
Jan 26, 2022 Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... CGMP Deviations Class II
Jan 26, 2022 Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab ... CGMP Deviations Class II
Jan 26, 2022 Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 ... CGMP Deviations Class II
Jan 26, 2022 APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULT... CGMP Deviations Class II
Jan 26, 2022 APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc... CGMP Deviations Class II
Jan 26, 2022 Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAta... CGMP Deviations Class II
Jan 26, 2022 Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ... CGMP Deviations Class II
Jan 26, 2022 Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratorie... CGMP Deviations Class II
Jan 26, 2022 Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II
Jan 26, 2022 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... CGMP Deviations Class II
Jan 26, 2022 Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... CGMP Deviations Class II
Jan 26, 2022 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... CGMP Deviations Class II
Jan 26, 2022 Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, ... CGMP Deviations Class II
Jan 26, 2022 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, UL... CGMP Deviations Class II
Jan 26, 2022 Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAt... CGMP Deviations Class II
Jan 26, 2022 DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packe... CGMP Deviations Class II
Jan 26, 2022 Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab... CGMP Deviations Class II
Jan 26, 2022 Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg,... CGMP Deviations Class II
Jan 26, 2022 HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylam... CGMP Deviations Class II
Jan 26, 2022 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethor... CGMP Deviations Class II
Jan 26, 2022 Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTR... CGMP Deviations Class II
Jan 26, 2022 Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II
Jan 26, 2022 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, UL... CGMP Deviations Class II
Jan 26, 2022 Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Labo... CGMP Deviations Class II
Jan 26, 2022 Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrin... CGMP Deviations Class II
Jan 26, 2022 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... CGMP Deviations Class II
Jan 26, 2022 APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... CGMP Deviations Class II
Nov 29, 2021 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... CGMP Deviations: failed stability results, inadequate laboratory investigations, Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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