The Recall Desk

Hazard

Manufacturing Deviation recalls

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

What the numbers show

Total
294
Critical
0
Severe
6
Most recent
2026-07-08

Of the 294 manufacturing deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (2%) 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 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.

226–250 of 294

  • ModerateFDA (Drugs)·D-0628-2022·2022-03-02

    Nasal Spray Oxymetazoline HCl Recalled Due to Contaminated Excipient

    Perrigo Company PLC is recalling Nasal Maximum Strength Nasal Spray (Oxymetazoline HCl 0.05%) due to contamination from a recalled excipient used during manufacturing. Approximately 2,302 bottles were distributed nationwide.

    Product
    NASAL — NASAL (OXYMETAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0599-2022·2022-03-02

    Equate Children's Pain and Fever recalled due to contaminated excipient

    Perrigo Company is recalling Equate Children's Pain and Fever (Acetaminophen) oral suspension nationwide due to manufacturing deviations involving contaminated excipient from a supplier.

    Product
    EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2022·2022-03-02

    Equate Children's Pain and Fever Acetaminophen Suspension Recall

    Perrigo Company is recalling Equate Children's Pain and Fever Acetaminophen Suspension (160mg/5ml) due to contaminated excipient used in manufacturing. Approximately 117,552 bottles distributed nationwide are affected.

    Product
    EQUATE CHILDRENS PAIN AND FEVER — EQUATE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0721-2022·2022-02-16

    Caffeine and vitamin dietary supplement tablets recalled for manufacturing practice deviations

    ULTRAtab Laboratories recalls Ephrine Plus dietary supplement tablets due to manufacturing practice deviations. The recall involves 4,250,842 tablets distributed to bulk distributors in New York and Florida.

    Product
    Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0728-2022·2022-02-16

    Melatonin ER supplement recalled for manufacturing practice deviations

    ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.

    Product
    Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0727-2022·2022-02-16

    Dietary supplement melatonin recall due to manufacturing deviations

    ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.

    Product
    Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0723-2022·2022-02-16

    Caffeine dietary supplement recalled due to manufacturing practice deviations

    ULTRAtab Laboratories' caffeine and vitamin B-complex supplement is being recalled due to cGMP (Good Manufacturing Practice) deviations. The voluntary recall affects approximately 1,904,760 tablets distributed to wholesalers.

    Product
    Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0725-2022·2022-02-16

    Caffeine vitamin supplement tablets recalled for manufacturing deviations

    ULTRAtab Laboratories is voluntarily recalling 1,393,353 caffeine supplement tablets due to manufacturing practice deviations.

    Product
    Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0528-2022·2022-02-16

    Drug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling Coated APAP 325 mg Phenylephrine HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects bulk product distributed to three distributors.

    Product
    Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0550-2022·2022-02-16

    Pain Aid PMF Caplet Drug Recall for CGMP Deviations

    ULTRAtab Laboratories is recalling Pain Aid PMF Caplets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.6 million tablets in bulk form distributed to three distributors.

    Product
    Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-710-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0526-2022·2022-02-16

    Drug recall: Kramer Novis Tusicof caplet CGMP deviations

    ULTRAtab Laboratories is recalling Kramer Novis Tusicof caplets due to current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 639,729 tablets distributed to three wholesalers.

    Product
    Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0546-2022·2022-02-16

    Drug Recall: Phenylephrine HCl 5mg Tablets Bulk Container

    ULTRAtab Laboratories is recalling approximately 7.9 million Coated Phenylephrine HCl 5mg tablets in bulk containers due to manufacturing process deviations that may affect product quality and safety.

    Product
    Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0724-2022·2022-02-16

    Caffeine vitamin supplement recalled for manufacturing process deviations

    ULTRAtab Laboratories has recalled 1.6 million tablets of a caffeine and B-vitamin supplement due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.

    Product
    Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0478-2022·2022-02-09

    Multi Symptom Cold Relief tablets recalled for cGMP deviations

    Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) deviations.

    Product
    Multi 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 02917
    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-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-0480-2022·2022-02-09

    Cold Relief Drug Recalled for Manufacturing Deviations

    Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.

    Product
    Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
    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-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-0516-2022·2022-02-09

    REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    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-0492-2022·2022-02-09

    Drug Recall: PAINAID Tablets for Manufacturing Deviations

    Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.

    Product
    PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
    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-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-0432-2022·2022-02-02

    CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations

    Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.

    Product
    CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
    Category
    Drug
    Distribution
    Distributed nationwide