The Recall Desk

Hazard

Manufacturing Compliance recalls

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

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2026-07-01

Of the 17 manufacturing compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 compliance 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.

1–17 of 17

  • ModerateFDA (Drugs)·D-0611-2026·2026-07-01

    Fenofibrate Capsules 200 mg Recalled for CGMP Manufacturing Deviations

    Ajanta Pharma USA Inc. is recalling Fenofibrate Capsules, USP 200 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during production. The recall affects 3,648 bottles distributed nationwide.

    Product
    FENOFIBRATE — FENOFIBRATE (FENOFIBRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0346-2025·2025-04-16

    Naproxen Sodium tablets recalled due to manufacturing compliance deviations

    Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall affects lot #17231956 with expiration date Aug-25.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0262-2025·2025-03-19

    FDA recalls finasteride drug for manufacturing compliance deviations

    Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.

    Product
    Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0847-2023·2023-06-07

    Sufenta Injection Recalled Due to Manufacturing Compliance Deviations

    Akorn Inc. is recalling all lots of Sufenta (Sufentanil Citrate Injection) distributed nationwide. The manufacturer ceased operations and could not complete required stability studies to verify drug safety and effectiveness over time.

    Product
    Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0519-2023·2023-04-12

    Rosuvastatin Calcium Tablets Recalled for Manufacturing Deviations

    Preferred Pharmaceuticals, Inc. is recalling Rosuvastatin Calcium 10 mg tablets nationwide due to cGMP deviations identified during FDA inspection of the manufacturing facility.

    Product
    ROSUVASTATIN CALCIUM — ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0850-2022·2022-05-11

    Betamethasone Dipropionate Ointment 0.05% recalled for manufacturing compliance failures

    McKesson Corporation is recalling 55,440 tubes of Betamethasone Dipropionate Ointment 0.05% (Augmented) nationwide due to manufacturing compliance deviations. The recall stems from the manufacturer's discontinuation of its stability study program.

    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram 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 381
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2022·2022-02-23

    Dental Resins Recalled for Manufacturing Facility and Origin Labeling Violations

    Envisiontec US LLC recalled 795 units of FLEXCERA SMILE dental resins manufactured between April 2021 and September 2021 because they were produced in a non-FDA-registered facility and falsely labeled as German origin.

    Product
    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2022·2022-02-09

    Sinus Decongestant Nasal Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 448,300 packets of SINUS DECONGESTANT (phenylephrine HCl 5mg) tablets due to current Good Manufacturing Practice (cGMP) deviations. The recall affects nationwide distribution.

    Product
    SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0518-2022·2022-02-09

    Sinus Relief Drug Recall for cGMP Manufacturing Deviations

    Ultra Seal Corporation is recalling Sinus Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. Affected lots are AK9651 (exp. 06/2022) and AK9437 (exp. 01/2022).

    Product
    Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2022·2022-02-09

    Magnacal Calcium Carbonate Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling MAGNACAL calcium carbonate 420 mg tablets (Lot #AK9768, expiration 08/2022) nationwide due to current Good Manufacturing Practice (cGMP) deviations. The voluntary recall was initiated on January 24, 2022.

    Product
    MAGNACAL (calcium carbonate 420 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0517-2022·2022-02-09

    REMfresh Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0508-2022·2022-02-09

    Nutralox Mint Antacid Chewable Tablets Recalled for cGMP Deviations

    Ultra Seal Corporation is recalling 1,486,050 packets of Nutralox Mint Antacid chewable tablets (calcium carbonate 420mg, 2-count packets) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Nutralox Mint Antacid (calcium carbonate 420mg) Chewable tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
    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-0446-2022·2022-02-02

    Promethazine HCl Topical Ointment Recalled for CGMP Deviations

    Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.

    Product
    Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2022·2022-02-02

    Vitamin K Oral Solution Recalled for CGMP Deviations

    Edge Pharma is recalling 757 syringes of Vitamin K Oral Solution nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall was initiated voluntarily by the firm and has been terminated.

    Product
    Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0515-2022·2022-01-26

    Mango Ginger Pickle from Unapproved Source Recalled

    Aroma Meats LLC is recalling Mango Ginger Pickle (Fresh Mamidi Allam) packaged in 500-gram white plastic pouches because the product was sourced from an unapproved manufacturer. The product was distributed in Oregon.

    Product
    Mango Ginger Pickle (Fresh Mamidi Allam) was packaged in white plastic pouch, net wt. 1/2 KG (500 grams). No UPC. Labeled with Aroma Meats name but has no address. The label is read in parts: "***FRESH MAMIDI ALLAM ***(MANGO GINGER PICKLE)***1/2 KG (500GMS) ***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0695-2021·2021-08-04

    Drug Recall: Estriol USP41 Micro Due to cGMP Deviations

    API Solutions Inc. is recalling Estriol USP41 Micro 25 Grams (Lot #ETL181001) due to cGMP deviations. The product was distributed to AL, AZ, CO, FL, and VA.

    Product
    Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
    Category
    Drug
    Distribution
    5 states