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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7376–7400 of 17772

  • SevereFDA (Drugs)·D-1801-2019·2019-08-21

    Pembrolizumab Infusion Recalled Due to Lack of Sterility Assurance

    Infusion Options, Inc. is recalling Pembrolizumab 200 mg/100 mL IV products in New York due to a lack of assurance of sterility.

    Product
    PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1813-2019·2019-08-21

    Infusion Options Recalls SOLIRIS IV Products Due to Sterility Concerns

    Infusion Options, Inc. is recalling SOLIRIS 1200 mg and 900 mg IV products in New York due to a lack of assurance of sterility.

    Product
    SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1765-2019·2019-08-21

    Infusion Options Recalls DARZALEX Infusion Bags Due to Sterility Concerns

    Infusion Options, Inc. is recalling DARZALEX 1008 mg / 500 mL IV infusion bags in New York due to a lack of assurance of sterility.

    Product
    DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1781-2019·2019-08-21

    Infusion Options Recalls Gemcitabine Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Gemcitabine infusion bags in New York due to a lack of assurance of sterility.

    Product
    Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS IVPB; Gemcitabine 880 MG / 250 ML NS IVPB; Gemcitabine 810 MG / 250 ML NS IVPB; Gemcitabine 820 MG / 250 ML NS IVPB; Gemcitabine 17
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1757-2019·2019-08-21

    Infusion Options Recalls Carfilzomib Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various strengths of Carfilzomib infusions in New York due to a lack of assurance of sterility.

    Product
    CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CARFILZOMIB 50 MG IN 50 ML D5W IVPB; CARFILZOMIB 45 MG IN 50 ML D5W IVPB; CARFILZOMIB 46.2 MG IN 50 ML D5W IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1764-2019·2019-08-21

    DARATUMUMAB infusion products recalled due to lack of assurance of sterility

    The FDA is recalling DARATUMUMAB infusion solutions because sterility cannot be assured, creating a potential infection risk.

    Product
    DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1815-2019·2019-08-21

    Infusion Options Recalls Trastuzumab Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling multiple Trastuzumab infusion bags in New York due to a lack of assurance of sterility.

    Product
    TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; TRASTUZUMAB 757 MG / 250 ML NS IVPB TRASTUZUMAB 450 MG / 250 ML NS IVPB; TRASTUZUMAB 120 MG / 250 ML NS IVPB; TRASTUZUMAB 164 MG /
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1751-2019·2019-08-21

    Infusion Options Recalls Azacitidine Syringes Due to Sterility Concerns

    Infusion Options, Inc. is recalling Azacitidine syringes in New York due to a lack of assurance of sterility.

    Product
    AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1761-2019·2019-08-21

    Infusion Options Recalls Cyclophosphamide Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Cyclophosphamide infusion products in New York due to a lack of assurance of sterility.

    Product
    Cyclophosphamide 840 MG / 250 ML NS IVPB; Cyclophosphamide 1112 MG / 250 ML NS IVPB; Cyclophosphamide 1248 MG / 50 ML NS IVPB; Cyclophosphamide 1125 MG / 100 ML NS IVPB; Cyclophosphamide 1000 MG / 500 ML NS IVPB; Cyclophosphamide 1400 MG / 100 ML NS IVPB Cyclophosphamide 1056 MG
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1783-2019·2019-08-21

    Infusion Options Recalls HERCEPTIN Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling HERCEPTIN infusion bags in New York due to a lack of assurance of sterility.

    Product
    HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HERCEPTIN 526 MG / 250 ML NS IVPB; HERCEPTIN 162 MG / 250 ML NS IVPB; HERCEPTIN 354 MG/ 250 ml 0.9% NACL IVPB; HERCEPTIN 440 MG / 250
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1769-2019·2019-08-21

    Infusion Options Recalls Docetaxel Infusions Due to Sterility Concerns

    Infusion Options, Inc. is recalling various Docetaxel infusion bags in New York due to a lack of assurance of sterility.

    Product
    DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 150 MG / 250 ml NS IVPB; DOCETAXEL 137 mg / 250 ml 0.9% NACL IVPB; DOCETAXEL 130 MG/ 250 ml NS IVPB; DOCETAXEL 140 MG/ 250 ml NS IVPB
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1738-2019·2019-08-21

    US Pharmaceuticals Recalls Cool Hot Ice Analgesic Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling 246 cases of Cool Hot Ice Analgesic Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1821-2019·2019-08-21

    Carbamazepine Extended-Release Tablets Recalled for Failed Dissolution Specifications

    American Health Packaging is recalling Carbamazepine Extended-Release Tablets, 400 mg, because they failed to meet dissolution specifications.

    Product
    Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1732-2019·2019-08-21

    US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues

    US Pharmaceuticals is recalling specific lots of Maximum Strength Hydrocortisone Cream with Aloe because the purified water used in manufacturing failed quality tests.

    Product
    MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE — MAXIMUM STRENGTH HYDROCORTISONE CREAM WITH ALOE (HYDROCORTISONE CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1741-2019·2019-08-21

    US Pharmaceuticals Recalls CRYO-273 Cold Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CRYO-273 Cold Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1734-2019·2019-08-21

    US Pharmaceuticals Recalls Hydrocortisone Cream Due to Water Quality Issues

    US Pharmaceuticals is recalling 651 cases of Maximum Strength Hydrocortisone Cream because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    MAXIMUM STRENGTH HYDROCORTISONE CREAM — MAXIMUM STRENGTH HYDROCORTISONE CREAM (HYDROCORTISONE CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1740-2019·2019-08-21

    US Pharmaceuticals Recalls Wonder Freeze Pain Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling Wonder Freeze Pain Relieving Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1735-2019·2019-08-21

    US Pharmaceuticals Recalls Soothe&Cool Protect Moisture Guard Skin Protectant

    US Pharmaceuticals is recalling 830 tubes of Soothe&Cool Protect Moisture Guard Skin Protectant due to out-of-specification results for microbial count or organic carbon in purified water.

    Product
    Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1729-2019·2019-08-21

    US Pharmaceuticals Recalls Adult Glycerin Suppositories Due to Water Quality Issues

    US Pharmaceuticals is recalling 196 cases of Adult Glycerin Suppositories because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Adult Glycerin Suppositories, Package Size 50-count suppositories, Distributed By: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015. NDC#0363-0441-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1726-2019·2019-08-21

    US Pharmaceuticals Recalls CVS Therapeutic Menthol Gel Due to Water Quality Issues

    US Pharmaceuticals is recalling CVS Therapeutic Menthol Gel because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1724-2019·2019-08-21

    CVS Health Glycerin Suppositories Recalled for Water Quality Issues

    US Pharmaceuticals is recalling CVS Health Glycerin Suppositories due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.

    Product
    CVS Health Glycerin Suppositories, 50-count box, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 33106 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1739-2019·2019-08-21

    US Pharmaceuticals Recalls Kool Comfort Cooling Pain Relief Due to Water Quality Issues

    US Pharmaceuticals is recalling Kool Comfort Cooling Pain Relief because the purified water used in manufacturing failed quality tests for microbial count or organic carbon.

    Product
    Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee La
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1725-2019·2019-08-21

    US Pharmaceuticals Recalls Intensive Healing Eczema Lotion for Water Quality Issues

    US Pharmaceuticals is recalling Intensive Healing Eczema Lotion due to out-of-specification results for microbial count or organic carbon in the purified water used during manufacturing.

    Product
    INTENSIVE HEALING ECZEMA — INTENSIVE HEALING ECZEMA (HYDROCORTISONE)
    Category
    Drug
    Distribution
    Distributed nationwide