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.

1451–1475 of 1563

  • LowFDA (Drugs)·D-1492-2016·2016-09-14

    Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2016·2016-08-31

    Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Package
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1052-2016·2016-07-06

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they were manufactured using active ingredients that failed specifications.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1041-2016·2016-06-29

    Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 163 boxes of Vermox Tablets 100 mg due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1040-2016·2016-06-29

    Profarma Recalls tabcin NOCHE Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 31 boxes of tabcin NOCHE capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin NOCHE; Capsules,12-count box, UPC 501008485033
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1039-2016·2016-06-29

    Profarma Recalls tabcin ACTIVE M.R. Capsules Due to Manufacturing Deviations

    Profarma Distributors LLC is voluntarily recalling 42 boxes of tabcin ACTIVE M.R. Capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0955-2016·2016-06-08

    Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations

    Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates failed specifications.

    Product
    Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0951-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0952-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0954-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0953-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0782-2016·2016-04-06

    Praxair Recalls 127 Cylinders of Compressed Medical Air Due to Odor

    Praxair Inc. is recalling 127 cylinders of compressed medical air because a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0783-2016·2016-04-06

    Praxair Recalls Medical Air Cylinders Due to Odor Complaint

    Praxair Inc. is recalling 382 cylinders of medical air nationwide after a customer reported an odor when turning on a cylinder.

    Product
    UN1002 Air, Compressed, Medical Air, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0776-2016·2016-03-23

    Medical Park Homecare Recalls Compressed Oxygen Cylinders Due to Gauge Issues

    Medical Park Homecare is recalling compressed oxygen cylinders filled using out-of-date gauges. The recall involves M6, D, and E tanks distributed in Oklahoma.

    Product
    Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1347-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA LLC is recalling 3,378 bottles of Lisinopril 20 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 94106 5, NDC 64679-941-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1346-2015·2015-08-26

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigations

    Wockhardt USA is recalling 1,704 bottles of Lisinopril 5 mg tablets because an FDA inspection found inadequate investigations of past market complaints.

    Product
    Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1258-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.

    Product
    Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 W
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1268-2015·2015-07-29

    Wockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations

    Wockhardt USA is recalling 16,276 bottles of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1265-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.

    Product
    Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1249-2015·2015-07-29

    Wockhardt Recalls Clarithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 59,729 bottles of Clarithromycin 500 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1262-2015·2015-07-29

    Wockhardt Recalls Zolpidem Tartrate Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Zolpidem Tartrate 10 mg tablets because the company did not adequately investigate customer complaints, a violation of current Good Manufacturing Practices.

    Product
    Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0705
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1256-2015·2015-07-29

    Wockhardt Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Amlodipine Besylate 10 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 U
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1246-2015·2015-07-29

    Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations

    Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.

    Product
    Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippan
    Category
    Drug
    Distribution
    Distributed nationwide