The Recall Desk

Hazard

Quality Control recalls

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

What the numbers show

Total
349
Critical
0
Severe
124
Most recent
2026-09-02

Of the 349 quality control recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 124 (36%) 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 quality control 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.

176–200 of 349

  • ModerateFDA (Drugs)·D-1219-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling Amlodipine besylate tablets 5mg due to CGMP deviations involving inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1228-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

    American Health Packaging is recalling 5,591 cartons of Lisinopril 20mg tablets nationwide because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1225-2015·2015-07-15

    Famotidine tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling 97,837 cartons of Famotidine tablets 20mg due to CGMP deviations involving inadequate investigation of customer complaints.

    Product
    Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for America
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1134-2015·2015-06-24

    Allegiant Health Recalls Famotidine Tablets Due to Manufacturing Investigation Failures

    Allegiant Health is recalling specific lots of over-the-counter famotidine tablets because the manufacturer failed to adequately investigate customer complaints.

    Product
    Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1110-2015·2015-06-03

    Blenheim Pharmacal Recalls Clarithromycin Tablets Due to cGMP Deviations

    Blenheim Pharmacal is recalling 50 bottles of Clarithromycin Tablets 500 mg in Indiana due to cGMP deviations and inadequate complaint investigation.

    Product
    Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1018-2015·2015-05-20

    Health Innovations Pharmacy Recalls Voriconazole Eye Drops for Sterility Concerns

    Health Innovations Pharmacy is recalling Voriconazole 1% Opth Drops due to quality control issues affecting sterility and stability data.

    Product
    Voriconazole 1% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2015·2015-05-20

    Health Innovations Pharmacy Recalls Methenamine Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Methenamine/Phenyl Salicylate Capsules due to quality control issues that may affect sterility and stability.

    Product
    Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-968-2015·2015-04-29

    Tarmac Recalls Well at Walgreens Antacid Liquid for Failed Antimicrobial Test

    Tarmac Products, Inc. is recalling Well at Walgreens Regular Strength Antacid Liquid because the product failed the Antimicrobial Effectiveness Test.

    Product
    Well at Walgreens Regular Strength Antacid Liquid, Mint Flavor 12 FL OZ (355 mL) bottle
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1452-2015·2015-04-22

    Integra Flowable Wound Matrix Recalled for Stability Criteria Failures

    Integra LifeSciences is recalling 287 packages of Flowable Wound Matrix because the product failed stability acceptance criteria for visual appearance and force vs. displacement.

    Product
    Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0487-2015·2015-04-22

    Apotex Recalls Bromfenac Ophthalmic Solution Due to CGMP Deviations

    Apotex Inc. is recalling 33,795 bottles of Bromfenac Ophthalmic Solution 0.09% because an excipient was not re-tested at the appropriate date.

    Product
    Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1380-2015·2015-03-11

    Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues

    Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.

    Product
    FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1584-2014·2014-11-26

    Medtronic Recalls ENT Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    ENT PRGM 9734636 ADD FUSION NAV AxiEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0174-2015·2014-11-12

    FDA Recalls Alprostadil/Lidocaine Vials Due to Sterility Assurance Concerns

    Oregon Compounding Centers is recalling Alprostadil/Lidocaine HCL vials due to quality control issues affecting sterility assurance identified during an FDA inspection.

    Product
    ALPROSTADIL/LIDOCAINE HCL, 20mcg/5mg/mL, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0194-2015·2014-11-12

    FDA Recalls Sterile Glutaraldehyde Solution Due to Quality Control Concerns

    Oregon Compounding Centers is recalling sterile glutaraldehyde solution for irrigation due to quality control issues affecting sterility assurance.

    Product
    GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, Wilsonville, OR 97070
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0237-2015·2014-11-12

    Physicians Total Care Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Physicians Total Care is recalling specific lots of Cephalexin Monohydrate Capsules because the active ingredients were not manufactured with good manufacturing practices.

    Product
    CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1572-2014·2014-09-10

    Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

    Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

    Product
    OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·051-2014·2014-08-09

    Oberto's Recalls Chicken Strips Due to Quality Control Issues

    Oberto's Brands is recalling approximately 57,578 pounds of chicken strips due to a company quality issue involving increased water activity.

    Product
    Recall Notification Report 051-2014
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1506-2014·2014-08-06

    Daiichi Sankyo Recalls Benicar Tablets Due to Temperature Abuse During Shipping

    Daiichi Sankyo is recalling Benicar Tablets (olmesartan medoxomil) 40 mg because some products were not stored at controlled room temperature during shipping.

    Product
    Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2104-2014·2014-07-30

    Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1631-2014·2014-05-28

    SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds

    SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.

    Product
    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1648-2014·2014-05-28

    Ortho-Clinical VITROS TT4 Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TT4 Calibrators due to potential calibration failures or low quality control results.

    Product
    VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differenti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1295-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.

    Product
    INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1293-2014·2014-05-21

    Teva Recalls Glyburide and Metformin Tablets Due to GMP Deviations

    Teva Pharmaceuticals USA is recalling specific bottles of Glyburide and Metformin Hydrochloride tablets due to laboratory testing deviations from GMP requirements.

    Product
    GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
    Category
    Drug
    Distribution
    Distributed nationwide