Unrated Drug recall · FDA · Published January 26, 2022
ULTRAtab APAP 500mg Tablets Recall: CGMP Deviations
ULTRAtab recalls acetaminophen 500mg tablets due to manufacturing deviations. Affected lots from Highland, NY. Consumers should contact for details.
Recall notice
CGMP Deviations
Contact the company
Recalling firmULTRAtab Laboratories, Inc.50 Toc Dr · Highland, NY 12528-1506
What happened, in plain English
ULTRAtab is recalling acetaminophen 500mg tablets produced in Highland, NY due to manufacturing deviations. This recall addresses potential quality issues that could affect product safety. Read more at govinfonow.com/recall/35249-ultratab-apap-500mg-tablets-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/35249-ultratab-apap-500mg-tablets-recall-cgmp-deviations · Updated August 18, 2026 · FDA enforcement record: FDA #D-0536-2022
Cite this page
“ULTRAtab APAP 500mg Tablets Recall: CGMP Deviations.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35249-ultratab-apap-500mg-tablets-recall-cgmp-deviations. Based on FDA recall #D-0536-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0536-2022%22&limit=1).
Why it’s dangerous
The product was made under CGMP (Current Good Manufacturing Practices) deviations, which means the manufacturing process didn't follow standard safety rules. This could lead to unsafe levels of acetaminophen in the tablets.
Who’s affected
People who bought ULTRAtab's acetaminophen 500mg tablets from Highland, NY. Those using these tablets for pain or fever relief are most at risk.
How to tell if you have this one
Check for the product code L210L on the packaging. The affected lots are 18L120, 19B044, and 19E082 from Highland, NY.
- Brand
ULTRAtab- Category
Drug
All 33 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0523-2022 | 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00; Product Code C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027 | 33,758,436 tablets |
| D-0524-2022 | 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00; Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067 | 19,103,287 tablets |
| D-0525-2022 | Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx; Product Codes: C111L Bulk Lot: 18L028 | 1,798,048 tablets |
| D-0526-2022 | Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00; Product Codes: C119L Bulk Lots: 18K028 | 639,729 tablets |
| D-0527-2022 | Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00; Product Codes: C121L Bulk Lots: 19G074, 19G075 | 917,304 tablets |
| D-0528-2022 | 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; Product Codes: C134LC Bulk Lots: 18K055 18M081 19A097 19B024 19C054 19E092 19G094 19J042 | 14,566,510 tablets |
| D-0529-2022 | APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00; Product Codes: C135LA Bulk Lots: 19F077 | 451,123 tablets |
| D-0530-2022 | APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00; Product Codes: C140L Bulk Lots: 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051 | 14,349,148 tablets |
| D-0531-2022 | APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-200-00; Product Codes: L200L Bulk Lots: 18K072, 19C049 | 3,677,483 tablets |
| D-0532-2022 | Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00; Product Codes: L202L Bulk Lots: 18K013, 18K014, 18K015, 19A040, 18M076, 19A041, 19H072, 19H073, 19H074 | 16,429,211 tablets |
| D-0533-2022 | Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00; Product Codes: L203L Bulk Lots: 18K012, 19E091 | 3,667,885 tablets |
| D-0534-2022 | Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00; Product Codes: L206L Bulk Lots: 19B002 | 2,048,941 tablets |
| D-0535-2022 | Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00; Product Codes: L207L Bulk Lots: 18K111, 19E104, 19F050 | 6,215,512 tablets |
| D-0536-2022 | APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00; Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082 | 6,249,082 tablets |
| D-0537-2022 | APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-211-00; Product Codes: L211L Bulk Lots: 18M043, 18M044, 18M045, 19B032, 19B033, 19B034, 19F008, 19F009, 19F010 | 18,772,640 tablets |
| D-0538-2022 | HPC 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; Product 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 | 50,585,623 tablets |
| D-0539-2022 | Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00; Product Code: M303 Bulk lots: 19C042, 19C043, 19F083; Product Code: M303A Bulk Lot: 19E105 | 3,349,387 tablets |
| D-0540-2022 | Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00; Product Codes: M304 Bulk Lots: 18K059, 18L106, 18L117, 18M067, 18M068 | 3,052,313 tablets |
| D-0541-2022 | Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00; Product Codes: M310 Bulk Lots: 19C044, 19H015 | 3,050,308 tablets |
| D-0542-2022 | Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00; Product Codes: M311 Bulk Lots: 19A069 | 1,527,203 tablets |
| D-0543-2022 | Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00; Product Codes: M312 Bulk Lots: 18J004, 18J005, 18C045, 19C046 | 5,923,518 tablets |
| D-0544-2022 | Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-320-00; Product Codes: M320L Bulk Lots: 18M063, 19G076 | 7,297,709 tablets |
| D-0545-2022 | Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00; Product Codes: M333 Bulk Lots: 18M065, 19J078 | 4,531,580 tablets |
| D-0546-2022 | Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00; Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043 | 7,983,360 tablets |
| D-0547-2022 | Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00; Product Codes: M565L Bulk Lots: 19F014 | 990,197 tablets |
| D-0548-2022 | APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-700-00; Product Codes: M700LA Bulk Lots: 18K037, 18L093, 18M006, 19A121, 19G044, 19G045, 19G046 | 6,380,282 tablets |
| D-0549-2022 | Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00; Product Codes: M701L Bulk Lots: 19G077 | 452,038 tablets |
| D-0550-2022 | Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00; Product Codes: M710L Bulk Lots: 19A071 | 1,585,375 tablets |
| D-0551-2022 | Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00; Product Codes: M740LA Bulk Lots: 19C022, 19C023 | 1,477,641 tablets |
| D-0552-2022 | Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00; Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050 | 14,066,434 tablets |
| D-0553-2022 | Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00; Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037 | 25,769,495 tablets |
| D-0554-2022 | DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-941-00; Product Codes: M941L M940LA Bulk Lots: 19C065, 19F081, 19H083, 17D088 | 8,727,657 tablets |
| D-0555-2022 | Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00; Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098 | 37,464,418 tablets |
What to do — step by step
Contact Manufacturer
ULTRAtab Laboratories, Inc. should be contacted for specific instructions on what to do with the recalled product.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0536-2022 (January 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0536-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.