The Recall Desk

Hazard

Cgmp Violation recalls

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

What the numbers show

Total
108
Critical
0
Severe
3
Most recent
2026-07-08

Of the 108 cgmp violation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) 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 violation 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.

51–75 of 108

  • HighFDA (Drugs)·D-1135-2022·2022-06-22

    Homeopathic drug Proteus recalled for manufacturing quality control deviations

    Washington Homeopathic Products is recalling Proteus homeopathic remedy in multiple potencies due to manufacturing process deviations. The firm initiated this voluntary recall in May 2022.

    Product
    Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1141-2022·2022-06-22

    Homeopathic Drug Recall: Vaccinotoxinum Products Due to Manufacturing Violations

    Washington Homeopathic Products is recalling Vaccinotoxinum homeopathic remedies (lot numbers 2512K and 20280) distributed nationwide due to cGMP manufacturing deviations. The voluntary recall was initiated by the firm in May 2022.

    Product
    Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1140-2022·2022-06-22

    Drug recall: Tuberculinum Bovinum due to manufacturing practice deviations

    Washington Homeopathic Products is recalling Tuberculinum Bovinum homeopathic remedy due to current good manufacturing practice deviations. No illnesses have been reported.

    Product
    Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1089-2022·2022-06-15

    Injectable Steroid Suspension Recalled Due to Manufacturing Temperature Control Deviation

    Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials nationwide.

    Product
    Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1001-2022·2022-06-15

    Bupivacaine HCl Injection Recalled for Temperature Control Deviation

    McKesson Medical-Surgical is recalling Bupivacaine HCl Injection (0.50%, multi-dose vials, NDC 55150-0250-50) due to cGMP deviations related to temperature abuse during manufacturing. The product was distributed nationwide.

    Product
    Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0814-2022·2022-05-04

    FDA Recalls Compounded Injectable Medication RE-2 Due to Manufacturing Deviations

    Olympia Compounding Pharmacy is recalling 2,201 vials of RE-2, a compounded injectable medication, because environmental and personnel monitoring deviations were not properly investigated prior to October 2021.

    Product
    RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0795-2022·2022-05-04

    NAD+ Compounded Drug Recall for Manufacturing Quality Control Violations

    Olympia Compounding Pharmacy is recalling NAD+ lyophilized powder (16,329 vials nationwide) due to failure to properly investigate environmental and personnel monitoring violations in manufacturing.

    Product
    NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0819-2022·2022-05-04

    Alprostadil Injection Recalled Over Manufacturing Quality Control Failures

    Olympia Compounding Pharmacy recalled PGE-3 Alprostadil 150 mcg/mL injection due to manufacturing facility failure to properly investigate environmental and personnel monitoring excursions.

    Product
    PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0796-2022·2022-05-04

    Diluent for Reconstitution Recalled Due to Manufacturing Compliance Failures

    Olympia Pharmacy has recalled 45,935 vials of pharmaceutical diluent due to manufacturing compliance deviations. Environmental and personnel monitoring limits were exceeded and not properly investigated prior to October 2021.

    Product
    Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0813-2022·2022-05-04

    Compounded Injectable Drug Recalled Due to Manufacturing Process Violations

    Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.

    Product
    RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0826-2022·2022-05-04

    FDA Recalls Hydroxocobalamin B12 Injection for Manufacturing Control Failures

    Olympia Compounding Pharmacy recalls 6,431 vials of Hydroxocobalamin B12 injection nationwide due to manufacturing quality control failures. Environmental and personnel monitoring systems prior to October 2021 did not properly investigate deviations from acceptable limits.

    Product
    Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2022·2022-05-04

    Sincalide Injectable Vials Recalled for Manufacturing Monitoring Failures

    Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide due to CGMP deviations in environmental and personnel monitoring. The manufacturer failed to properly investigate monitoring excursions prior to October 2021.

    Product
    Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0678-2022·2022-03-30

    Desoximetasone Ointment USP Recalled by Teligent Pharma

    Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.

    Product
    Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0675-2022·2022-03-30

    Desonide Ointment Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).

    Product
    Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0693-2022·2022-03-30

    Lidocaine Cream 4% Recalled Due to cGMP Deviations

    Teligent Pharma is recalling all unexpired Lidocaine Cream 4% due to manufacturing quality deviations. The firm has discontinued its stability study program.

    Product
    Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jer
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0626-2022·2022-03-02

    Equate Nasal Spray Recalled for Contaminated Excipient Manufacturing Defect

    Perrigo Company PLC is recalling Equate Nasal No Drip Nasal Spray because the product was manufactured with a contaminated excipient that was previously recalled from the supplier.

    Product
    EQUATE NASAL — EQUATE NASAL (OXYMETAZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-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-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 (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-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-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-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-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