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.

1526–1550 of 1563

  • 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
  • SevereFDA (Drugs)·D-1545-2014·2014-08-27

    Fresenius Kabi Recalls Propranolol Hydrochloride Injection Due to API Deficiencies

    Fresenius Kabi USA, LLC is recalling 56,060 vials of Propranolol Hydrochloride Injection because the active ingredient supplier received citations for critical manufacturing deficiencies.

    Product
    PROPRANOLOL — PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2014·2014-08-13

    SST Corporation Recalls Tetrahydrozoline HCL Due to CGMP Deviations

    SST Corporation is recalling Tetrahydrozoline HCL drums because they were stored in a non-GMP compliant warehouse in Italy.

    Product
    Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1510-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1511-2014·2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations

    Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

    Product
    INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
    Category
    Drug
    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)·D1292-2014·2014-05-21

    Teva Recalls Methyldopa Tablets Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, due to CGMP deviations and laboratory testing not following GMP requirements.

    Product
    METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2014·2014-03-12

    Teva Recalls Ethambutol Hydrochloride Tablets Due to Incorrect Excipient

    Teva Pharmaceuticals is recalling specific lots of Ethambutol Hydrochloride Tablets because they were manufactured with an unapproved gelatin excipient.

    Product
    Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1094-2014·2014-03-12

    Teva Recalls Dextroamphetamine Tablets Due to CGMP Deviations

    Teva Pharmaceuticals is recalling specific lots of Dextroamphetamine tablets because they were manufactured using unapproved material and not properly quarantined.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2014·2014-03-12

    Teva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.

    Product
    HYDROXYZINE PAMOATE — HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-406-2014·2014-01-22

    Betachem Recalls Metformin Hydrochloride API Due to CGMP Deviations

    Betachem, Inc. is recalling 27,000 kilos of Metformin Hydrochloride USP active pharmaceutical ingredient because it was not manufactured according to current good manufacturing practices.

    Product
    Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No. 10828-
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-66403-009·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-010·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-005·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

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

    Product
    Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-002·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to CGMP Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-011·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66403-004·2013-11-13

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 521 bottles of Ciprofloxacin 250 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66403-006·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66403-007·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66403-001·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 2.5 mg, because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1064-2013·2013-10-09

    Marlex Acetaminophen Tablets Recalled for Manufacturing Practice Deviations

    Marlex Pharmaceuticals is recalling 28,387 bottles of Acetaminophen Tablets, 500 mg, because the lot was not manufactured under current good manufacturing practices.

    Product
    Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-891-2013·2013-08-21

    Total Resources International Recalls 326-Piece First Aid Kits Due to Stability Failures

    Total Resources International is voluntarily recalling 326-piece first aid kits because the active ingredient Benzalkonium Chloride failed stability testing.

    Product
    (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789
    Category
    Consumer Product
    Distribution
    Distributed nationwide