The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 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 283 (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 1552

  • 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-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-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-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-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
  • 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-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-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-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-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-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
  • 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
  • ModerateFDA (Drugs)·D-0773-2022·2022-04-27

    Diclofenac Sodium Topical Solution Recalled Due to Manufacturing Quality Deviations

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution because the manufacturing firm discontinued its stability study program, a CGMP violation. All products within their expiration dates are affected.

    Product
    Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0771-2022·2022-04-20

    Econazole Nitrate Cream Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals is recalling Econazole Nitrate Cream 1% due to CGMP deviations. The manufacturer discontinued its stability study program; affected lots were distributed in California and Florida.

    Product
    Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0757-2022·2022-04-13

    Accuretic Blood Pressure Tablets Recalled for Excess Chemical Impurity

    Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.

    Product
    Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc, NY, NY 10017, Made in Germany, NDC 0071-0223-23.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0740-2022·2022-03-30

    Hand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination

    Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.

    Product
    HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0681-2022·2022-03-30

    Diflorasone Diacetate Ointment recalled due to discontinued stability studies

    Teligent Pharma is recalling all unexpired Diflorasone Diacetate Ointment 0.05% due to cGMP deviations. The company discontinued its stability study program, preventing verification that the product maintains safety and effectiveness throughout shelf life.

    Product
    Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0683-2022·2022-03-30

    Fluocinonide Cream Recalled for Manufacturing Compliance and Stability Deviations

    Teligent Pharma, Inc. is recalling Fluocinonide Cream USP 0.1% due to manufacturing compliance deviations and discontinuation of stability studies. The recall affects products nationwide in the USA and Puerto Rico.

    Product
    Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0669-2022·2022-03-30

    FDA Recalls Betamethasone Dipropionate Lotion Due to Manufacturing Deviations

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0700-2022·2022-03-30

    Clobetasol Propionate Cream USP Recalled for cGMP Deviations

    Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP 0.05% in 60-gram tubes due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, affecting all products within expiry nationwide and in Puerto Rico.

    Product
    Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0690-2022·2022-03-30

    Hydrocortisone Butyrate Lotion recalled due to cGMP deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.

    Product
    Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0699-2022·2022-03-30

    Triamcinolone Acetonide Ointment Recalled Due to cGMP Deviations

    Teligent Pharma is recalling Triamcinolone Acetonide Ointment USP 0.1% nationwide because the manufacturer is discontinuing its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation.

    Product
    Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0703-2022·2022-03-30

    Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations

    Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.

    Product
    Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
    Category
    Drug
    Distribution
    Distributed nationwide