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.

1501–1525 of 1563

  • ModerateFDA (Drugs)·D-1270-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mu
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1260-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1267-2015·2015-07-29

    Wockhardt Recalls Famotidine Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling 1,002 drums of Famotidine Tablets, USP, 10 mg because the firm did not adequately investigate customer complaints.

    Product
    Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1238-2015·2015-07-22

    Geritrex Recalls Carb-O-Philic 40 Cream Due to Container Closure Deviation

    Geritrex Corp is recalling Carb-O-Philic 40 Cream due to a CGMP deviation involving poor container closure of the bulk storage container.

    Product
    Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1230-2015·2015-07-15

    Zonisamide capsules recalled for inadequate complaint investigation

    American Health Packaging is recalling Zonisamide capsules due to current good manufacturing practice deviations involving inadequate investigation of customer complaints.

    Product
    Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); 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-1224-2015·2015-07-15

    American Health Packaging Recalls Clarithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling 3,572 cartons of Clarithromycin tablets, USP 500mg, because the firm did not adequately investigate customer complaints.

    Product
    Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-437-11); 5 blister packs per carton (NDC 68084-279-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ame
    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-1220-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling Amlodipine besylate tablets 10 mg due to current Good Manufacturing Practice (CGMP) deviations involving inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1221-2015·2015-07-15

    American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1227-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    American Health Packaging is recalling 13,532 cartons of Lisinopril 10mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); 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-1222-2015·2015-07-15

    American Health Packaging Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    American Health Packaging is recalling 838 cartons of Azithromycin 600mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464-11); 3 blister packs per carton (NDC 68084-464-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Ameri
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1226-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

    American Health Packaging is recalling 4,718 cartons of Lisinopril 5mg tablets due to inadequate investigation of customer complaints.

    Product
    Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); 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-1229-2015·2015-07-15

    American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

    American Health Packaging is recalling Lisinopril tablets 40mg due to inadequate investigation of customer complaints. The recall covers 1,516 cartons distributed nationwide.

    Product
    Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); 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-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-1223-2015·2015-07-15

    American Health Packaging Recalls Azithromycin Tablets Due to CGMP Deviations

    American Health Packaging is recalling 2,068 cartons of Azithromycin tablets 250mg due to inadequate investigation of customer complaints.

    Product
    Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for Amer
    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-1218-2015·2015-07-15

    Amlodipine besylate tablets recalled for inadequate complaint investigation

    American Health Packaging is recalling 1,896 cartons of Amlodipine besylate tablets 2.5mg due to inadequate investigation of customer complaints.

    Product
    Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA f
    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
  • 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
  • SevereFDA (Drugs)·D-0377-2015·2015-01-28

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Institutional, Inc. is recalling Ciprofloxacin Tablets 500 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0378-2015·2015-01-28

    Mylan Lamotrigine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling 3,993 cartons of Lamotrigine 200 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0320-2015·2014-12-31

    Sunmark Eye Drops Recalled for Non-GMP API Storage

    K C Pharmaceuticals is recalling Sunmark Eye Drops because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    SUNMARK EYE DROPS ORIGINAL FORMULA — SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0321-2015·2014-12-31

    KC Pharmaceuticals Recalls Eye Drops Due to Non-GMP API Storage

    KC Pharmaceuticals is recalling 302,976 bottles of Eye Drops A.C. because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    Eye Drops A.C. (Tetrahydrozoline HCl 0.05%, Zinc sulfate 0.25%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Astringent Redness Reliever, Distributed by Safeway Inc., P.O. Box 99, Pleasanton, CA 94566-0009, UPC: 3 21130 70067 8; b) Best Choice, Distributed By: Valu
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0322-2015·2014-12-31

    K C Pharmaceuticals Recalls Eye Drops Due to Warehouse Storage Issues

    K C Pharmaceuticals is recalling specific lots of Eye Drops Industrial Strength because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0323-2015·2014-12-31

    KC Pharmaceuticals Recalls Sunmark Eye Drops for CGMP Deviations

    KC Pharmaceuticals is recalling Sunmark Eye Drops Advanced Moisturizer/Lubricant because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT — SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT (DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE)
    Category
    Drug
    Distribution
    Distributed nationwide