The Recall Desk

Hazard

Cgmp Deviations recalls

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

What the numbers show

Total
49
Critical
0
Severe
13
Most recent
2026-09-09

Of the 49 cgmp deviations recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (27%) 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 deviations 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.

1–25 of 49

  • SevereFDA (Drugs)·D-0809-2026·2026-09-09

    Baxter Recalls Famotidine Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Famotidine Injection due to CGMP deviations. The product was distributed in the US, Puerto Rico, and Chile.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0810-2026·2026-09-09

    Baxter Recalls Dexmedetomidine Hydrochloride Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Dexmedetomidine Hydrochloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0814-2026·2026-09-09

    Baxter Recalls Nexterone Amiodarone Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Nexterone (amiodarone hydrochloride) injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    NEXTERONE — NEXTERONE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0811-2026·2026-09-09

    Baxter Recalls Vasopressin Injection Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Vasopressin in 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE — VASOPRESSIN IN 0.9% SODIUM CHLORIDE (VASOPRESSIN IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0812-2026·2026-09-09

    Baxter Recalls Pantoprazole Sodium Infusion Bags Due to Manufacturing Deviations

    Baxter Healthcare is voluntarily recalling specific lots of Pantoprazole Sodium infusion bags due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston is recalling fentanyl citrate injectable solution (1000 mcg/50 mL) due to current good manufacturing practice (cGMP) deviations. The recall affects 150 syringes distributed nationwide.

    Product
    fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0325-2025·2025-04-16

    Glenmark Pharmaceuticals Recalls Pravastatin Sodium Tablets 80mg

    Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Pravastatin Sodium Tablets 80mg due to Current Good Manufacturing Practice (CGMP) deviations. The recall applies to affected lots distributed nationwide and was initiated voluntarily by the firm.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0330-2025·2025-04-16

    Glenmark Lacosamide 100mg Tablets Recalled for CGMP Deviations

    Glenmark Pharmaceuticals is recalling Lacosamide 100mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated this voluntary recall on March 13, 2025.

    Product
    LACOSAMIDE — LACOSAMIDE (LACOSAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0530-2022·2022-02-16

    Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations

    ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

    Product
    APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0547-2022·2022-02-16

    Migrenol Caplet Drug Recalled for CGMP Deviations

    ULTRAtab Laboratories is recalling Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 990,197 tablets distributed to three distributors.

    Product
    Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0437-2022·2022-02-02

    LET Topical Gel drug recall for CGMP deviations

    Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.

    Product
    LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) due to current good manufacturing practice (cGMP) deviations. The recall is voluntary and affects nationwide distribution in the US.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0826-2021·2021-09-29

    Zonisamide Capsules Recalled by Glenmark Due to CGMP Deviations

    Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Zonisamide Capsules USP 100 mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations. The recall affects multiple lot numbers distributed from August 2021.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0660-2021·2021-07-21

    Cipla Solifenacin Succinate Tablets Recalled for CGMP Deviations

    Cipla USA is recalling 7,228 bottles of Solifenacin Succinate Tablets, 10 mg (Lot #GG90819, expiring 06/2021) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0363-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy Handwash Due to Manufacturing Deviations

    Spartan Chemical Co Inc is voluntarily recalling 1,200 cases of Lite'n Foamy Eucalyptus Mint Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    LITE NFOAMY EUCALYPTUS MINT SANITIZING HANDWASH — LITE NFOAMY EUCALYPTUS MINT SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0246-2021·2021-02-10

    Taro Recalls Nortriptyline Hydrochloride Capsules Due to Manufacturing Deviations

    Taro Pharmaceuticals is recalling 44,256 bottles of Nortriptyline Hydrochloride capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    NORTRIPTYLINE HYDROCHLORIDE — NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0170-2021·2020-12-30

    Akebia Recalls Auryxia Tablets Due to Manufacturing Deviations

    Akebia Therapeutics is voluntarily recalling 2,170 bottles of Auryxia (ferric citrate) tablets due to CGMP deviations. The FDA classified this as a Class II recall.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0121-2021·2020-12-16

    Shilpa Medicare Recalls Busulfan Injection Due to Manufacturing Deviations

    Shilpa Medicare Limited is voluntarily recalling 2,064 vials of Busulfan Injection due to CGMP deviations. The recall is nationwide and the lot expired in December 2020.

    Product
    Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0126-2021·2020-12-16

    Shilpa Medicare Recalls Docetaxel Injection Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 2,008 vials of Docetaxel Injection USP due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2021·2020-12-16

    Shilpa Medicare Recalls Azacitidine Injection Vials Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 6,560 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and nationwide.

    Product
    Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2021·2020-11-18

    H & H Remedies Recalls White Liniment Due to CGMP Deviations

    H & H Remedies, LLC is voluntarily recalling 365 bottles of White Liniment due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1628-2020·2020-10-07

    Akorn Recalls Eye Itch Relief Eye Drops Due to Manufacturing Deviations

    Akorn, Inc. is voluntarily recalling 25,843 bottles of Eye Itch Relief eye drops due to CGMP deviations. The product was distributed nationwide in 14 states.

    Product
    Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1623-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is voluntarily recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1622-2020·2020-09-30

    Preferred Pharmaceuticals Recalls Nature-Throid Tablets Due to CGMP Deviations

    Preferred Pharmaceuticals is recalling specific lots of Nature-Throid tablets due to Current Good Manufacturing Practice (CGMP) deviations. The affected repackaged tablets were sold to three physicians in California and Georgia.

    Product
    Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09
    Category
    Drug
    Distribution
    2 states