The Recall Desk

Hazard

Gmp Deviation recalls

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

What the numbers show

Total
108
Critical
0
Severe
16
Most recent
2026-04-08

Of the 108 gmp deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (15%) 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 gmp 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.

26–50 of 108

  • ModerateFDA (Drugs)·D-0378-2026·2026-03-11

    Antimicrobial alcohol hand wipes recalled over manufacturing practice deviations

    Acme United Corporation is recalling Antimicrobial Alcohol Hand Wipes containing 70% isopropyl alcohol over current good manufacturing practice deviations.

    Product
    Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0495-2024·2024-05-22

    Gordofilm Wart Remover Recalled Due to Manufacturing Deviations

    Gordofilm Wart Remover by Gordon Laboratories is being recalled nationwide due to Current Good Manufacturing Practice (cGMP) deviations. The FDA classified this as a Class II recall on May 13, 2024.

    Product
    Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0372-2024·2024-03-20

    Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation

    Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.

    Product
    Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0373-2024·2024-03-20

    Pfizer Bicillin L-A Prefilled Syringes Recalled for Improper Storage

    Mckesson is recalling Bicillin L-A prefilled syringes stored outside label specifications. The FDA Class II recall affects 70 vials distributed to direct accounts in NM, AZ, and UT.

    Product
    Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0886-2023·2023-07-05

    FDA Recalls StellaLife VEGA Oral Care Rinse for Manufacturing Deviations

    The FDA is recalling StellaLife VEGA Oral Care Rinse nationwide due to current Good Manufacturing Practice (cGMP) deviations. The manufacturer voluntarily initiated the recall.

    Product
    STELLALIFE VEGA ORAL CARE RINSE — STELLALIFE VEGA ORAL CARE RINSE (RINSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0864-2023·2023-06-07

    Tropicamide Ophthalmic Solution Recalled by Akorn for CGMP Deviations

    Akorn Operating Company is recalling all lots of Tropicamide Ophthalmic Solution 0.1% nationwide due to Good Manufacturing Practice (CGMP) deviations. The firm ceased operations and could not complete required stability studies.

    Product
    Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2023·2023-04-12

    Doxazosin Tablets Recalled Due to Manufacturing Practice Deviations

    Preferred Pharmaceuticals recalls Doxazosin Tablets USP 2 mg (Lot H3122K, expires 5/31/2024) due to current Good Manufacturing Practice deviations identified at the manufacturing facility.

    Product
    Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2023·2023-04-12

    Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations

    RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.

    Product
    Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2023·2023-04-05

    Drug Recall: Glimepiride Tablets Due to Manufacturing Deviations

    Direct Rx is recalling Glimepiride, USP, 1 mg Tablets nationwide due to cGMP deviations. The firm-initiated recall impacts both 30-count and 90-count bottles distributed across the USA.

    Product
    Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0254-2023·2023-02-08

    Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

    Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution due to manufacturing practice deviations. The recall affects 144 bottles distributed in Puerto Rico.

    Product
    Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0084-2023·2022-12-21

    Homeopathic Calendula Oil Recalled for Manufacturing Practice Violations

    Atlantic Management Resources voluntarily recalls Menastil homeopathic calendula oil due to cGMP deviations. The 26 bottles (Lot A-01) were distributed nationwide and to Australia.

    Product
    Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0001-2023·2022-10-12

    Hand Sanitizer Spray Recalled for Above-Specification Chemical Contamination

    Salon Technologies International is recalling Sanitizing Hand Spray 80% due to GMP deviations: the product contains acetaldehyde and acetal above specification limits. The recall affects 1,656 bottles distributed in Florida and Washington.

    Product
    Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1465-2022·2022-09-07

    Colgate OPTIC WHITE PRO Series Toothpaste Recalled for Improper Storage

    Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1345-2022·2022-08-24

    IV Trisodium Citrate Solution Recalled for Potential Cross-Contamination Risk

    Nephron Sterile Compounding Center is recalling 294 bags of Trisodium Citrate 0.5% Solution IV bags due to potential cross-contamination from manufacturing deviations. The affected lots were distributed nationwide.

    Product
    Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 6937
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2022·2022-06-22

    Homeopathic Colibacillinum Drug Recall Due to Manufacturing Deviations

    Washington Homeopathic Products recalls Colibacillinum homeopathic drug products due to manufacturing practice deviations. The recall involves 206 bottles distributed nationwide; the manufacturer voluntarily initiated it in May 2022.

    Product
    Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1095-2022·2022-06-15

    Bupivacaine Hydrochloride Injection Recalled Due to Manufacturing Temperature Deviations

    McKesson Medical-Surgical Inc. is recalling Bupivacaine Hydrochloride injections distributed nationwide due to manufacturing deviations involving temperature abuse that may have compromised the drug's potency and sterility.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2022·2022-06-15

    OTC Antacid E-Z-GAS Recalled for Manufacturing Temperature Control Deviations

    McKesson Medical-Surgical Inc. recalls E-Z-GAS II antacid product distributed nationwide due to cGMP deviations resulting from temperature abuse during manufacturing.

    Product
    E-Z-GAS — E-Z-GAS (ANTACID/ANTIFLATULENT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0093-2021·2020-11-25

    Milbar Recalls Willa Pore Perfector Pads Due to GMP Deviations

    Milbar Laboratories is recalling 2,638 jars of Willa Pore Perfector pads due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    Willa Pore Perfector (Salicylic Acid 2%) pads, 30 pads
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0092-2021·2020-11-25

    Milbar Recalls Willa Clear Skin Salicylic Acid Tubes Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 4,855 tubes of Willa Clear Skin (Salicylic Acid 2%) due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    Willa Clear Skin (Salicylic Acid 2%), 4.2 fl oz 124ml tubes, WBC Group LLC, Dist. Chandler, AZ 85226
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0085-2021·2020-11-25

    Milbar Recalls DCL AHA Lightening Gel Due to GMP Deviations

    Milbar Laboratories is recalling 1,608 bottles of DCL AHA Lightening Gel due to Good Manufacturing Practice deviations. The product was distributed nationwide and internationally.

    Product
    DCL AHA Lightening Gel (hydroquinone 2%), 30 ml/1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486500471
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0088-2021·2020-11-25

    Milbar Recalls Malin + Goetz Dandruff Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling 5,312 bottles of Malin + Goetz dandruff shampoo due to Good Manufacturing Practice deviations.

    Product
    (Malin + Goetz) dandruff Shampoo Psoriasis and Sebborrheic Dermatitis (1.9% Pyrithione Zinc) 8 fl.oz bottle, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0083-2021·2020-11-25

    Milbar Recalls DCL Active Mattifying Cleanser Due to GMP Deviations

    Milbar Laboratories is recalling 4,878 tubes of DCL Active Mattifying Cleanser due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Active Mattifying Cleanser (Salicylic Acid 2%), 125mL/4.2 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486509627
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0096-2021·2020-11-25

    Milbar Recalls Salicylic Acid Shampoo Due to GMP Deviations

    Milbar Laboratories is recalling Salicylic Acid Shampoo 3% due to Good Manufacturing Practice deviations. The product was distributed in the US and internationally.

    Product
    Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0090-2021·2020-11-25

    Milbar Recalls Malin+Goetz SPF 30 Face Moisturizer Due to GMP Deviations

    Milbar Laboratories is recalling 3,692 tubes of Malin+Goetz SPF 30 Face Moisturizer due to Good Manufacturing Practice (GMP) deviations.

    Product
    (Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0094-2021·2020-11-25

    Milbar Recalls DCL Alpha Beta Gel Toner Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling DCL Alpha Beta Gel Toner due to Good Manufacturing Practice (GMP) deviations. The product was distributed nationwide and internationally.

    Product
    DCL Alpha Beta Gel Toner (1.95% Salicylic Acid) 200 mL/6.7 fl. oz, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state