State

Indiana product recalls

73,486 recalls have nationwide distribution and so reach Indiana. 9,589 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,589
Critical: 1,913
Severe: 2,528
Most recent: 2026-10-14

Of the 9,589 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,528 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,589 recalls whose distribution notice names Indiana specifically. The 73,486 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

24251–24275 of 83075

ModerateFDA (Drugs)·D-0518-2022·2022-02-09
Sinus Relief Drug Recall for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).
Product
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0467-2022·2022-02-09
Acetaminophen Pain Reliever Recalled for cGMP Deviations
Ultra Seal Corporation is recalling approximately 1.2 million packets of Maximum Strength Non Aspirin Pain Reliever/Fever Reducer due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide.
Product
Maximum 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 67060-210-68
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0468-2022·2022-02-09
Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations
Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.
Product
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0473-2022·2022-02-09
Ephedrine Plus tablets recalled for cGMP manufacturing deviations
Ultra Seal Corporation is recalling Ephedrine Plus tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 301,842 bottles distributed across the United States.
Product
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0517-2022·2022-02-09
REMfresh Melatonin Caplets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.
Product
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0494-2022·2022-02-09
PAINAID PMF Premenstrual Formula Recalled for cGMP Deviations
Ultra Seal Corporation voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Product
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0509-2022·2022-02-09
Drug Recall: FEM-PRIN Menstrual Relief Tablets for cGMP Deviations
Ultra Seal Corporation is recalling FEM-PRIN Menstrual Relief tablets (223,090 packets) distributed nationwide due to cGMP deviations. The recall was voluntary and initiated on January 24, 2022.
Product
FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0461-2022·2022-02-09
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
Teva Pharmaceuticals USA is recalling Doxylamine Succinate and Pyridoxine Hydrochloride delayed-release tablets because dissolution test results for the active ingredient fall below specification limits, which may affect drug effectiveness.
Product
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE — DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0477-2022·2022-02-09
Cetafen acetaminophen tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets in 2-count packets due to current good manufacturing practice (cGMP) deviations. The recall affects 915,770 packets distributed nationwide.
Product
Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0515-2022·2022-02-09
Electrolyte Supplement Tablets Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling approximately 1.47 million packets of Electrolyte Supplement Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
Product
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0470-2022·2022-02-09
Legatrin PM Pain Reliever/Sleep Aid Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 174,852 bottles of Legatrin PM Pain Reliever/Sleep Aid nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated on January 24, 2022.
Product
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0466-2022·2022-02-09
AERO TAB Cold Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling AERO TAB Cold Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 226,390 packets of the product distributed nationwide.
Product
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0514-2022·2022-02-09
MIRALAC Calcium Carbonate Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MIRALAC calcium carbonate 420mg tablets in mint flavor due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 409,890 packets distributed nationwide.
Product
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2022·2022-02-09
Cold/Sinus Medication Recalled for Manufacturing Process Violations
Ultra Seal Corporation is recalling 301,650 packets of a Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant due to cGMP deviations discovered during manufacturing. The product was distributed nationwide.
Product
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0498-2022·2022-02-09
Regular Strength Pain Reliever recalled for cGMP deviations
Ultra Seal Corporation is recalling approximately 1.18 million packets of Regular Strength Pain Reliever nationwide due to current good manufacturing practice (cGMP) deviations.
Product
Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0505-2022·2022-02-09
CVS Health Natural Sleep Aid Chewable Tablets Recalled for Manufacturing Deviations
CVS Health Natural Sleep Aid Chewable Tablets (melatonin 1.5mg) in cherry flavor are being recalled nationwide due to cGMP manufacturing deviations. The manufacturer, Ultra Seal Corporation, initiated the voluntary recall of 241,560 bottles.
Product
CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2022·2022-02-09
Drug Recall: PEPTIME Energy Tablets cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 250mg) tablets distributed nationwide due to manufacturing practice deviations. The recall affects 156,096 packets and 9,648 bottles.
Product
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2022·2022-02-09
Drug Recall: CONGESTAID II Nasal Decongestant for Manufacturing Deviations
Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant packets due to current Good Manufacturing Practice (cGMP) deviations. The voluntary nationwide recall affects 447,050 packets.
Product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0481-2022·2022-02-09
Multi-Symptom Cramp Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation recalled 1,351,660 packets of Multi-Symptom Cramp Relief nationwide due to current good manufacturing practice (cGMP) deviations. The recall was voluntarily initiated and affects two lots with expiration dates in January and July 2022.
Product
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0496-2022·2022-02-09
Mint Flavored Antacid Recalled for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling 1,309,800 packets of Mint Flavored Antacid (Calcium Carbonate 420mg) distributed nationwide due to cGMP deviations. The recall is voluntary and applies to specific lot numbers with expiration dates in 2022.
Product
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2022·2022-02-09
Drug Recall: Cold Relief Tablets Due to cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Cold Relief tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product is distributed nationwide in the United States.
Product
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2022·2022-02-09
PAPENOL acetaminophen 500 mg packets recalled for cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen 500 mg (2 tablet packets) nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 533,100 packets with lot numbers K9495 (exp. 02/2022) and AK9614 (exp. 05/2022).
Product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0471-2022·2022-02-09
CYSTEX Urinary Pain Relief tablets recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling CYSTEX Urinary Pain Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects specific lot numbers distributed in 40-count and 20-count blister packages.
Product
CYSTEX — CYSTEX (METHENAMINE, SODIUM SALICYLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2022·2022-02-09
Medical Device QC Kit Component Bears Incorrect Expiration Date Label
Microbiologics Inc is recalling KWIK-STI(TM) GBS QC Set components with a mislabeled expiration date. The Lactobacillus acidophilus component was labeled 7/31/2020 instead of 7/31/2022.
Product
KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0511-2022·2022-02-09
CETAFEN Extra Acetaminophen 500 mg caplets recalled for manufacturing deviations
Ultra Seal Corporation is recalling CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets in 2-count packets nationwide due to current good manufacturing practice (cGMP) deviations.
Product
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
Category
Drug
Distribution
Distributed nationwide