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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

ULTRAtab Over-the-Counter Tablets Recalled for Manufacturing Violations

Agency Publication Date: February 9, 2022
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Summary

ULTRAtab Laboratories, Inc. is recalling 326,858,877 tablets across various over-the-counter brands and product categories, including pain relievers like Legatrin (acetaminophen), cold medicines, and specialty treatments like Cystex (sodium salicylate/methenamine). The recall was issued because the products were manufactured under conditions that did not meet current good manufacturing practice (CGMP) standards, which may impact the safety, quality, or consistency of the drugs. No injuries or adverse health events have been reported to date.

Risk

Manufacturing violations mean these medications may not meet federal standards for quality, identity, or purity, which could result in incorrect doses or unknown contaminants. Using medications that fail to meet these standards poses a potential health risk, although no specific incidents have been reported.

What You Should Do

  1. This recall affects over 326 million tablets of various over-the-counter medications including acetaminophen (APAP), cold and flu relief, antacids, and specialty medications like Legatrin, Cystex, and DBI Magnums.
  2. Check your medication packaging for the product name, NDC number, and lot codes listed on the label. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact ULTRAtab Laboratories, Inc. at 1-845-691-1000 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg)
Variants: Bulk Container
Lot Numbers:
18J080
18L029
19A103
19B063
19D019
19F065
18K045
18K046
18L008
18L105
19A068
19A094
19A106
19B009
19C031
19C032
19C033
19G085
19H070
19D018
19H071
19H082
19J027
NDC:
62959-106-00
Product: 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg)
Variants: Bulk Container
Lot Numbers:
18G085
19B061
19F066
19J068
18J051
18M079
18M080
19B017
19B018
19C001
19C081
19D056
19D057
19F067
NDC:
62959-107-00
Product: Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg)
Variants: Bulk Container
Lot Numbers:
18L028
NDC:
62959-111-xx
Product: Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg)
Variants: Bulk Container
Lot Numbers:
18K028
NDC:
62959-124-00
Product: Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg)
Variants: Bulk Container
Lot Numbers:
19G074
19G075
NDC:
62959-121-00
Product: Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg)
Variants: Bulk Container
Lot Numbers:
18K055
18M081
19A097
19B024
19C054
19E092
19G094
19J042
NDC:
62959-134-00
Product: APAP 325 mg/Phenylephrine HCl, 5mg Tablets
Variants: Bulk Container
Lot Numbers:
19F077
NDC:
62959-135-00
Product: APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg)
Variants: Bulk Container
Lot Numbers:
18K017
18L002
19C064
19E067
19F064
19H053
19J023
19J051
NDC:
62959-140-00
Product: APAP 325 mg (Acetaminophen 325 mg)
Variants: Bulk Container
Lot Numbers:
18K072
19C049
NDC:
62959-200-00
Product: Coated APAP 325mg (Acetaminophen 325 mg)
Variants: Bulk Container
Lot Numbers:
18K013
18K014
18K015
19A040
18M076
19A041
19H072
19H073
19H074
NDC:
62959-202-00
Product: Normed APAP 325 mg (Acetaminophen 325 mg)
Variants: Bulk Container
Lot Numbers:
18K012
19E091
NDC:
62959-203-00
Product: Coated APAP 500 mg caplet (Acetaminophen 500 mg)
Variants: Bulk Container
Lot Numbers:
19B002
NDC:
62959-206-00
Product: Extra-Strength Unaspirin caplet (Acetaminophen 500 mg)
Variants: Bulk Container
Lot Numbers:
18K111
19E104
19F050
NDC:
62959-207-00
Product: APAP 500 mg tablet (Acetaminophen 500 mg)
Variants: Bulk Container
Lot Numbers:
18L120
19B044
19E082
NDC:
62959-210-00
Product: APAP 500 mg SRC Coated (Acetaminophen 500 mg)
Variants: Bulk Container
Lot Numbers:
18M043
18M044
18M045
19B032
19B033
19B034
19F008
19F009
19F010
NDC:
62959-211-00
Product: HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg)
Variants: Bulk Container
Lot Numbers:
18K086
18L009
18L050
18L083
18M025
18M073
18M098
19A010
19A084
19A105
19A107
19H014
18F072
18L119
19A067
19G043
19H040
NDC:
62969-242-00
Product: Peppermint Antacid tablet (Calcium Carbonate 420 mg)
Variants: Bulk Container
Lot Numbers:
19C042
19C043
19F083
19E105
NDC:
62959-303-00
Product: Cherry Antacid Tablet (Calcium Carbonate 420 mg)
Variants: Bulk Container
Lot Numbers:
18K059
18L106
18L117
18M067
18M068
NDC:
62959-304-00
Product: Trial Antacid Tablet (Calcium Carbonate 420 mg)
Variants: Bulk Container
Lot Numbers:
19C044
19H015
NDC:
62959-310-00
Product: Spearmint Antacid Tablet (Calcium Carbonate 420 mg)
Variants: Bulk Container
Lot Numbers:
19A069
NDC:
62959-311-00
Product: Nutralox Peppermint Antacid (Calcium Carbonate 420 mg)
Variants: Bulk Container
Lot Numbers:
18J004
18J005
18C045
19C046
NDC:
62959-312-00
Product: Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)
Variants: Bulk Container
Lot Numbers:
18M063
19G076
NDC:
62959-320-00
Product: Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg)
Variants: Bulk Container
Lot Numbers:
18M065
19J078
NDC:
62959-333-00
Product: Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg )
Variants: Bulk Container
Lot Numbers:
19A070
19B080
19J043
NDC:
62959-338-00
Product: Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg)
Variants: Bulk Container
Lot Numbers:
19F014
NDC:
62959-565-00
Product: APAP 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet)
Variants: Bulk Container
Lot Numbers:
18K037
18L093
18M006
19A121
19G044
19G045
19G046
NDC:
62959-700-00
Product: Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg)
Variants: Bulk Container
Lot Numbers:
19G077
NDC:
62959-701-00
Product: Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg)
Variants: Bulk Container
Lot Numbers:
19A071
NDC:
62959-710-00
Product: Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg)
Variants: Bulk Container
Lot Numbers:
19C022
19C023
NDC:
62959-740-00
Product: Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg)
Variants: Bulk Container
Lot Numbers:
18K029
18L059
18M100
19B013
19D024
19D059
19E029
19J050
NDC:
62959-785-00
Product: Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg)
Variants: Bulk Container
Lot Numbers:
18K005
18K075
18K098
18M064
19C021
19C050
19G081
19G082
19H012
19H013
19J036
19J037
NDC:
62959-800-00
Product: DBI Magnums Tablet (Caffeine 200 mg)
Variants: 100 and 500 count, 3 and 36 count packets, Bulk Container
Lot Numbers:
19C065
19F081
19H083
17D088
NDC:
62959-941-00
Product: Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg)
Variants: Bulk Container
Lot Numbers:
18J072
18K030
18L123
19A043
19A093
19B062
19C079
19C080
19D041
19E035
19E087
19G084
19H098
NDC:
62959-945-00

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89334
Status: Resolved
Manufacturer: ULTRAtab Laboratories, Inc.
Sold By: three distributors
Manufactured In: United States
Units Affected: 33 products (33,758,436 tablets; 19,103,287 tablets; 1,798,048 tablets; 639,729 tablets; 917,304 tablets; 14,566,510 tablets; 451,123 tablets; 14,349,148 tablets; 3,677,483 tablets; 16,429,211 tablets; 3,667,885 tablets; 2,048,941 tablets; 6,215,512 tablets; 6,249,082 tablets; 18,772,640 tablets; 50,585,623 tablets; 3,349,387 tablets; 3,052,313 tablets; 3,050,308 tablets; 1,527,203 tablets; 5,923,518 tablets; 7,297,709 tablets; 4,531,580 tablets; 7,983,360 tablets; 990,197 tablets; 6,380,282 tablets; 452,038 tablets; 1,585,375 tablets; 1,477,641 tablets; 14,066,434 tablets; 25,769,495 tablets; 8,727,657 tablets; 37,464,418 tablets)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.