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.

651–675 of 1563

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-0539-2022·2022-02-16
Peppermint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Product
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0536-2022·2022-02-16
Acetaminophen 500 mg tablets recalled for CGMP deviations
ULTRAtab Laboratories is recalling approximately 6.2 million acetaminophen 500 mg tablets due to current good manufacturing practice (CGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
Product
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0552-2022·2022-02-16
Legatrin Acetaminophen and Diphenhydramine Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Legatrin bulk tablets due to manufacturing deviations that may affect product quality and safety. The company voluntarily initiated the recall after distributing approximately 14 million tablets to three distributors.
Product
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
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-0493-2022·2022-02-09
Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
Product
PAINAID 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 42961-0003-00
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-0506-2022·2022-02-09
MidNite Natural Sleep Aid Chewable Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 90,072 bottles distributed across the United States.
Product
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
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-0510-2022·2022-02-09
Cough & Cold Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 225,000 packets of CETAFEN Cough & Cold coated tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects Lot #AK9841 with expiration date 10/2022.
Product
CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg) Coated tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
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-0487-2022·2022-02-09
Cold Terminator decongestant recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling Cold Terminator decongestant/cold relief tablets due to manufacturing compliance deviations. The recall affects 226,400 packets distributed nationwide.
Product
COLD 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 69103-2556
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2022·2022-02-09
Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations
Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.
Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0476-2022·2022-02-09
Drug Recall: Back Pain-Off Tablets Over cGMP Violations
Ultra Seal Corporation is voluntarily recalling Back Pain-Off tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 1.96 million 2-count packets distributed across the United States.
Product
Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0507-2022·2022-02-09
Exaprin Pain Reliever Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Exaprin pain reliever tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects approximately 1.14 million packets distributed across the United States.
Product
Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 2- tablet packets, Manufactured for: HARTHealth Seattle, WA 98124
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