Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,563
Critical: 1
Severe: 289
Most recent: 2026-09-09

Of the 1,563 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 289 (18%) 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 cgmp deviation 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.

676–700 of 1563

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-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-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-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-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-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 (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
ModerateFDA (Drugs)·D-0464-2022·2022-02-09
Nasal & Sinus Decongestant Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Nasal & Sinus Decongestant packets containing phenylephrine HCl 5mg due to current good manufacturing practice (cGMP) deviations. The recall affects 3,508,200 packets distributed nationwide.
Product
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0512-2022·2022-02-09
AYPANAL Pain Reliever Tablets Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling AYPANAL Non-aspirin Pain Reliever tablets (acetaminophen 325 mg) in 2-count packets nationwide due to Current Good Manufacturing Practice (cGMP) deviations.
Product
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0479-2022·2022-02-09
Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.
Product
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0513-2022·2022-02-09
Sinus Decongestant Nasal Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.
Product
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0503-2022·2022-02-09
PEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 350mg) tablets due to cGMP (current good manufacturing practice) deviations. The recall affects 113,040 packets and 7,132 bottles distributed nationwide.
Product
PEPTIME Energy (caffeine 350mg) 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-0475-2022·2022-02-09
Drug recall: MidNite Sleep Health melatonin tablets, cGMP deviations
Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.
Product
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0443-2022·2022-02-02
Phenol Topical Solution recalled for CGMP manufacturing deviations
Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0441-2022·2022-02-02
Profound-PE Dental Gel Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.
Product
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0445-2022·2022-02-02
Vitamin K Oral Solution Recalled for CGMP Deviations
Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.
Product
Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0435-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to CGMP Deviations
Edge Pharma, LLC is recalling 20 vials of Dibutyl Squaric Acid topical solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The drug was distributed in multiple dose vials containing 1%, 10 mL each.
Product
Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0429-2022·2022-02-02
Drug Recall: Cantharidin Gel-Forming Suspension CGMP Deviations
Edge Pharma, LLC is recalling Cantharidin Gel-Forming Suspension 0.7% nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall involves 1173 vials distributed to healthcare facilities.
Product
Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0449-2022·2022-02-02
Trypan Blue Ophthalmic Solution Recalled for CGMP Deviations
Edge Pharma, LLC is recalling Trypan Blue 0.03% ophthalmic solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily on December 6, 2021.
Product
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2022·2022-02-02
Profound Dental Gel Recalled for CGMP Manufacturing Deviations
Edge Pharma, LLC is recalling 221 jars of Profound Dental Gel (Lidocaine/Prilocaine/Tetracaine 10%/10%/4%) nationwide due to Good Manufacturing Practice (CGMP) deviations identified during production.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0434-2022·2022-02-02
Dibutyl Squaric Acid Topical Solution Recalled Due to Manufacturing Deviations
Edge Pharma, LLC is recalling 63 vials of Dibutyl Squaric Acid Topical Solution (2%, 10 mL per vial) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03
Category
Drug
Distribution
Distributed nationwide