The Recall Desk

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
288
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 288 (18%) are Severe.

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.

526–550 of 1563

  • HighFDA (Drugs)·D-0974-2022·2022-06-08

    Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity

    Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0886-2022·2022-06-01

    Losartan HCTZ drug recall due to azido impurity levels above limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.

    Product
    Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0892-2022·2022-06-01

    Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations

    Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0888-2022·2022-06-01

    Zonisamide Capsules USP recalled for quality control system deviation

    Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.

    Product
    Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0874-2022·2022-05-25

    Pfizer Accupril Blood Pressure Tablets Recalled for Nitrosamine Contamination

    Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.

    Product
    Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0870-2022·2022-05-25

    Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation

    Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0847-2022·2022-05-11

    Halobetasol Propionate Ointment 0.05% Recalled Due to Manufacturing Practice Deviations

    McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% nationwide after the manufacturer discontinued its stability study program, creating CGMP deviations. Over 13,200 tubes distributed in the United States, Guam, and the Northern Mariana Islands are affected.

    Product
    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0848-2022·2022-05-11

    Lidocaine Hydrochloride Topical Solution Recalled for Manufacturing Quality Deviations

    McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution due to manufacturing deviations related to discontinuation of the stability study program. Approximately 81,757 bottles distributed nationwide are affected.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2022·2022-05-11

    FDA Recalls Lidocaine Prilocaine Cream Due to Manufacturing Compliance Issue

    McKesson Corporation has recalled Lidocaine Prilocaine Cream 2.5%/2.5% because the manufacturer, Teligent Pharma, Inc., discontinued its stability study program, a deviation from manufacturing standards.

    Product
    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0831-2022·2022-05-11

    Drug recall: Vancomycin HCl injection bags for manufacturing deviations

    SCA Pharmaceuticals has recalled Vancomycin HCl 1.5g injection bags due to manufacturing process deviations. The product was distributed nationwide.

    Product
    Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2022·2022-05-11

    Erythromycin Topical Gel Recalled Due to Manufacturing Quality Deviations

    McKesson Corporation is recalling Erythromycin Topical Gel USP 2% due to CGMP deviations. The manufacturer discontinued its stability study program, prompting a nationwide recall of all products within their expiration date.

    Product
    Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2022·2022-05-11

    Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations

    SCA Pharmaceuticals voluntarily recalled 424 bags of fentanyl and bupivacaine injectable solution due to manufacturing control deviations. The product was distributed nationwide in the United States.

    Product
    Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0808-2022·2022-05-04

    Injectable Drug SB-6 Recalled for Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy recalls SB-6 injectable drug due to manufacturing deficiencies. Prior to October 2021, environmental and personnel monitoring procedures were not properly investigated.

    Product
    SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0788-2022·2022-05-04

    Losartan Potassium 50 mg tablets recalled due to azido impurity

    RemedyRepack Inc. is recalling Losartan Potassium 50 mg tablets due to CGMP deviations with azido impurity levels above acceptable limits. The affected lots were distributed to customers in Alaska and Pennsylvania.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0810-2022·2022-05-04

    Compounded ST-2 pharmaceutical vials recalled for manufacturing process deviations

    Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical, nationwide due to manufacturing practice deviations and failures to properly investigate environmental and personnel monitoring excursions.

    Product
    ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0815-2022·2022-05-04

    Compounded injectable drug recalled for manufacturing monitoring deviations

    Olympia Compounding Pharmacy is recalling 388 vials of BIMIX-3 injection due to manufacturing process failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021, raising concerns about product quality.

    Product
    BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0806-2022·2022-05-04

    FDA Recalls Compounded Drug Due to Manufacturing Monitoring Deviations

    Olympia Compounding Pharmacy is recalling SB-4 due to manufacturing quality control failures. The company did not properly investigate environmental and personnel monitoring problems that occurred before October 2021.

    Product
    SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0807-2022·2022-05-04

    Compounded injectable drug recall for manufacturing process monitoring deviations

    Olympia Compounding Pharmacy recalls 1110 vials of SB-5 injectable (nationwide) due to failure to properly investigate environmental monitoring deviations prior to October 2021. No illnesses reported.

    Product
    SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0816-2022·2022-05-04

    FDA Recalls Compounded Injectable Drug Due to Manufacturing Control Failure

    Olympia Compounding Pharmacy is recalling a multi-drug injectable product nationwide due to manufacturing control deviations. The facility failed to properly investigate environmental and personnel monitoring excursions prior to October 2021.

    Product
    FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0800-2022·2022-05-04

    FDA Recalls Compounded Injectable Drug Formula F9 Due to CGMP Violations

    The FDA is recalling Formula F9, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring protocols were not properly followed, which could allow contamination.

    Product
    Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0821-2022·2022-05-04

    Compounded Injection Recalled Due to Manufacturing Process Monitoring Deviations

    Olympia Compounding Pharmacy recalled Formula F2 injectable (257 vials) due to improper investigation of manufacturing monitoring excursions before October 1, 2021. The product was distributed nationwide.

    Product
    Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0797-2022·2022-05-04

    Sermorelin Acetate Vials Recalled for Manufacturing Quality Control Deviations

    Olympia Pharmaceuticals is recalling approximately 18,060 vials of Sermorelin Acetate distributed nationwide due to manufacturing quality control deviations in which monitoring excursions were not properly investigated. Patients should contact their healthcare provider.

    Product
    Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2022·2022-05-04

    Alprostadil Injectable Drug Recalled for Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy is recalling 460 vials of Alprostadil 80 mcg/mL due to manufacturing quality control deviations related to improper investigation of environmental and personnel monitoring excursions prior to October 2021.

    Product
    PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0792-2022·2022-05-04

    Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide