The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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5651–5675 of 17772

  • 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 07726,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0117-2021·2020-12-16

    FDA Recalls Protz Antibacterial Hand Sanitizer for CGMP Violations

    Asiaticon, SA de CV is recalling 111,500 units of Protz Antibacterial Hand Sanitizer distributed in Texas due to a lack of Current Good Manufacturing Practices (CGMPs).

    Product
    Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019
    Category
    Drug
    Distribution
    1 state
  • 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-0120-2021·2020-12-16

    Fresenius Kabi Recalls Dexmedetomidine Injection Due to Lidocaine Contamination

    Fresenius Kabi is recalling 13,525 bottles of Dexmedetomidine HCl Injection due to cross-contamination with trace amounts of lidocaine.

    Product
    Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0116-2021·2020-12-16

    V-Klean Hand Sanitizer Gel Recalled for CGMP Violations

    Asiaticon, SA de CV is voluntarily recalling V-Klean Hand Sanitizer Gel Alcohol 70% due to a lack of Current Good Manufacturing Practices (CGMPs).

    Product
    V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0127-2021·2020-12-16

    Novocol Recalls Scandonest 3% Plain Due to Labeling Mix-Up

    Novocol Pharmaceutical is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. The product is distributed nationwide.

    Product
    SCANDONEST 3% PLAIN — SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0111-2021·2020-12-09

    Lohxa Recalls Chlorhexidine Gluconate Oral Rinse Due to Bacterial Contamination

    Lohxa LLC is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, due to contamination with Burkholderia lata bacteria.

    Product
    Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0118-2021·2020-12-09

    MPM Medical Recalls REGENECARE HA Topical Anesthetic Due to Bacteria

    MPM Medical LLC is recalling REGENECARE HA topical anesthetic hydrogel because it was found to be contaminated with Burkholderia cepacia bacteria.

    Product
    REGENECARE HA — REGENECARE HA (LIDOCAINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0114-2021·2020-12-09

    Harvard Drug Group Recalls Aripiprazole Tablets for Dissolution Failure

    The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.

    Product
    Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2021·2020-12-09

    Golden State Medical Supply Recalls Aripiprazole Tablets for Dissolution Concerns

    Golden State Medical Supply is recalling Aripiprazole 15 mg tablets due to potential out-of-specification dissolution limits.

    Product
    ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0113-2021·2020-12-09

    CVS Healing Ointment Recalled for Low Weight Fill Tubes

    US Pharmaceuticals is recalling CVS Health Hydrating Healing Ointment due to low weight fill tubes identified in one lot.

    Product
    CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0115-2021·2020-12-09

    InvaTech Recalls Levocetirizine Dihydrochloride Tablets Due to Stability Failure

    InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.

    Product
    Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0119-2021·2020-12-09

    Teligent Pharma Recalls Clobetasol Propionate Ointment Due to Potency Issues

    Teligent Pharma is recalling Clobetasol Propionate Ointment 0.05% because some tubes have superpotent or subpotent assay results.

    Product
    Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0102-2021·2020-12-02

    SYP Health Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    AA Products Inc. is recalling SYP Health Hand Sanitizer Alcohol Gel due to CGMP deviations and a history of subpotent ethanol and methanol contamination at the manufacturing facility.

    Product
    SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0103-2021·2020-12-02

    Paroex Oral Rinse Recalled for Burkholderia lata Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to microbial contamination with Burkholderia lata. The recall covers specific lots distributed nationwide.

    Product
    Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2021·2020-12-02

    Eywa Pharma Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

    Eywa Pharma Inc. is recalling 500 mg Levetiracetam tablets because a 1000 mg tablet was found in a 500 mg bottle.

    Product
    Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0110-2021·2020-12-02

    Teligent Recalls Subpotent Triamcinolone Acetonide Lotion

    Teligent Pharma is recalling one lot of Triamcinolone Acetonide Lotion because it does not meet assay results.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0107-2021·2020-12-02

    Fusion Health Immune Boost Recalled for Marketing Without FDA Approval

    Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost because the product was marketed with drug claims without an approved NDA or ANDA.

    Product
    Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0104-2021·2020-12-02

    Jubilant Cadista Recalls Clomipramine Hydrochloride Capsules Due to Specification Failure

    Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine hydrochloride capsules because they failed tablet/capsule specifications.

    Product
    clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0108-2021·2020-12-02

    Heritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities

    Heritage Pharmaceuticals is recalling specific bottles of Felodipine Extended Release Tablets because routine testing found out-of-specification impurities.

    Product
    Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
    Category
    Drug
    Distribution
    Distributed nationwide