Class IIOxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.2026-01-14
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Recalling firm: SpecGx, LLC
Class IITYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.2025-11-05
Defective Container
Recalling firm: Kenvue Brands LLC
Class IIAcetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India2025-04-16
CGMP Deviations
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIIAcetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.2025-01-22
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling firm: Akron Pharma, Inc.
Class IIKirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-812024-12-18
CGMP Deviations: Released product should have been rejected.
Recalling firm: LNK International, Inc.
Class IHealthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.2024-08-28
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Recalling firm: Aurobindo Pharma USA Inc
Class IIIAcetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India2024-08-14
Label mix-up: Carton incorrectly labeled.
Recalling firm: Granules Consumer Health Inc.
Class IIBroncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-442024-03-20
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recalling firm: Global Corporation
Class IRobitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 070592024-01-31
Microbial Contamination of Non-Sterile Products
Recalling firm: Haleon US Holdings LLC
Class IIAcetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs2023-06-07
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Recalling firm: Akorn, Inc.
Class IIAdvil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles2023-05-10
CGMP deviation: product outside labeled storage temperature requirements.
Recalling firm: Family Dollar Stores, Llc.
Class IIAcetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-702022-09-14
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm: Plastikon Healthcare LLC
Class IIAcetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-712022-09-14
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm: Plastikon Healthcare LLC
Class IICORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 02022-09-14
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm: Plastikon Healthcare LLC
Class IIAcetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-762022-09-14
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Recalling firm: Plastikon Healthcare LLC
Class IIAcetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.2022-05-25
CGMP Deviations: Failure to properly investigate failed microbial testing.
Recalling firm: Plastikon Healthcare LLC
Class IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIChildren's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIInfant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-162022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-262022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-162022-03-02
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm: Perrigo Company PLC
Class IIAPAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IIMigrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IICoated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IILegatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IINormed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class II4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IIHPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IICoated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IIExtra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-002022-02-16
CGMP Deviations
Recalling firm: ULTRAtab Laboratories, Inc.
Class IIPain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-682022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIBackache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-8322022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IICOLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus Medical Products, Carlsbad, CA 92011, NDC 69103-25562022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIAERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 109892022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIMaximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-682022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIDologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-022022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IICold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-032022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIPAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-002022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIDILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-052-032022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIMulti Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 029172022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIHeadache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-022022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIPAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-25072022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIPain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 450402022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IISinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 750072022-02-09
cGMP deviations
Recalling firm: Ultra Seal Corporation
Class IIRompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-082021-12-29
Microbial Contamination of Non-Sterile Products
Recalling firm: Efficient Laboratories, Inc.
Class IIHydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01.2021-12-15
Product Mix-up
Recalling firm: Ascent Pharmaceuticals, Inc.
Class IIIAdvance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)2021-11-03
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Recalling firm: Ultra Seal Corporation
Class IIIAfassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)2021-11-03
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Recalling firm: Ultra Seal Corporation
Class IAcetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.2021-05-12
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription dru
Recalling firm: A-S Medication Solutions LLC.
Class IIIPain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 750072020-08-26
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Recalling firm: Ultra Seal Corporation
Class IIAcetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 934332020-04-22
cGMP Deviations
Recalling firm: H J Harkins Company Inc dba Pharma Pac
Class IIMajor Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA2020-02-19
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000
Recalling firm: Contract Pharmacal Corporation