Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,441
Critical: 7
Severe: 114
Most recent: 2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

726–750 of 1441

ModerateFDA (Drugs)·D-0538-2022·2022-02-16
HPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling HPC Tablet (a combination of acetaminophen, aspirin, caffeine, and salicylamide) due to manufacturing deviations. The recall affects approximately 50 million tablets distributed in bulk to three distributors.
Product
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
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0542-2022·2022-02-16
Spearmint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Spearmint Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to manufacturing process deviations. The recall affects approximately 1.5 million tablets distributed to three distributors.
Product
Spearmint Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-311-00
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0726-2022·2022-02-16
Melatonin ER supplement recalled for manufacturing practice deviations
ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.
Product
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0533-2022·2022-02-16
Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
Product
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0524-2022·2022-02-16
Cold Tabs Drug Recalled for CGMP Manufacturing Deviations
ULTRAtab Laboratories is recalling 4-Component Cold Tabs in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed to three distributors.
Product
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
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0523-2022·2022-02-16
3-Component Cold Tabs Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is voluntarily recalling 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) in bulk container form due to Current Good Manufacturing Practice (CGMP) deviations.
Product
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0532-2022·2022-02-16
Acetaminophen 325 mg Tablets Recalled Due to Manufacturing Deviations
ULTRAtab Laboratories is recalling Coated APAP 325mg acetaminophen tablets sold in bulk containers due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects approximately 16.4 million tablets distributed to three wholesalers.
Product
Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-202-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0482-2022·2022-02-09
Backache & Muscle Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.
Product
Backache & 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 42961-111-832
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0490-2022·2022-02-09
DILOTAB II Sinus Cold Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling DILOTAB II Sinus and Cold Relief tablets nationwide due to cGMP (current good manufacturing practice) deviations. Approximately 2.7 million packets containing acetaminophen 325 mg and phenylephrine HCl 5 mg are affected.
Product
DILOTAB 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 42961-052-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0485-2022·2022-02-09
Pain Away Pain Reliever/Fever Reducer Drug Recall for cGMP Deviations
Ultra Seal Corporation is recalling 1,186,000 packets of Pain Away Pain Reliever/Fever Reducer nationwide due to manufacturing practice deviations. The recall was initiated by the firm on a voluntary basis.
Product
Pain 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 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0519-2022·2022-02-09
Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.
Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0501-2022·2022-02-09
PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling PEPTIME Energy 250mg caffeine tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 100-count bottles distributed in the United States.
Product
PEPTIME Energy (caffeine 250mg) tablets, 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-0472-2022·2022-02-09
DBI 357 Super Magnum Caffeine Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling DBI 357 Super Magnum Quick Energy Stimulant caffeine tablets distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall includes 36-count, 100-count, and 500-count bottles, as well as 3-count packets.
Product
DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets, packaged in a) 36-count bottles, b) 100-count bottles, c) 500-count bottles, and d) 3-count packets, Marketed by: DBI Distribution A Division of King Richard Promotions, Inc. P.O. Box 78546, Indianapolis, IN…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0474-2022·2022-02-09
Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.
Product
Dologen (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 52083-482-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0489-2022·2022-02-09
SINU-PHEN PLUS Sinus Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling SINU-PHEN PLUS sinus pain and congestion tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 122,400 packets distributed across the United States.
Product
SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2536-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0469-2022·2022-02-09
Extra Strength Pain Reliever Acetaminophen Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Extra Strength Pain Reliever (acetaminophen 500 mg) 2 tablet packets nationwide due to cGMP deviations. The recall affects Lot #AK9602 with expiration date 05/2022.
Product
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0488-2022·2022-02-09
Pain Terminator Extra Strength Pain Relief Drug Recall
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.
Product
PAIN 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 69103-2507
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0491-2022·2022-02-09
Extra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
Ultra Seal Corporation has voluntarily recalled 1,694,200 packets of Extra Strength Un-Aspirin (acetaminophen 500 mg) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
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-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-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-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-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-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