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 the agency’s own highest classification or reported deaths or serious injuries, 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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12251–12275 of 17987

  • SevereFDA (Drugs)·D-0890-2016·2016-06-01

    FDA Recalls Bull Capsules Marketed Without FDA Approval

    R Thomas Marketing, LLC is recalling Bull capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0861-2016·2016-06-01

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0865-2016·2016-06-01

    Hospira Recalls Sodium Bicarbonate Injection Due to Insect Particulate Matter

    Hospira Inc. is recalling 72,000 units of 8.4% Sodium Bicarbonate Injection because an insect was found in one vial.

    Product
    8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0893-2016·2016-06-01

    FDA Recalls African Superman Supplements Marketed Without Approval

    R Thomas Marketing, LLC is recalling African Superman supplements because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2016·2016-06-01

    Sanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System

    Sanofi-Aventis is recalling Auvi-Q epinephrine auto-injectors because a defective delivery system may result in inaccurate dosage delivery.

    Product
    Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0859-2016·2016-06-01

    Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.

    Product
    Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2016·2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0902-2016·2016-06-01

    FDA Recalls Mojo Risen Distributed Without Approved New Drug Application

    R Thomas Marketing, LLC is recalling Mojo Risen capsules nationwide because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0898-2016·2016-06-01

    Happy Passengers Recalled for Lack of FDA Approval

    R Thomas Marketing, LLC is recalling Happy Passengers capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2016·2016-06-01

    Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

    Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

    Product
    ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0858-2016·2016-06-01

    Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Defective Valve

    Lymol Medical is recalling Sclerosol Intrapleural Aerosol because a defective stem valve may cause the canister to leak propellant, resulting in no drug or an inadequate dose being delivered.

    Product
    Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0853-2016·2016-05-25

    Keystone Recalls Better Braid Un-Braid Due to Microbial Contamination

    Keystone Laboratories is recalling Better Braid Un-Braid salicylic acid product due to a failed S. aureus test. The product was distributed in Maryland and New Jersey.

    Product
    BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0855-2016·2016-05-25

    Renovo Patch Recalled for Lack of Approval and Subpotency

    TMIG Inc is recalling Renovo Patch because it was marketed without FDA approval and three lots were found to be subpotent.

    Product
    Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0856-2016·2016-05-25

    Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues

    Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.

    Product
    col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0854-2016·2016-05-25

    Hospira Recalls Magnesium Sulfate Injection Due to pH Failures

    Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.

    Product
    Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2016·2016-05-18

    Sesderma Salises Acne Gel Recalled for cGMP Deviations

    Sesderma is recalling Salises Facial Moisturizing Acne Treatment Gel due to cGMP deviations. The product does not comply with current Good Manufacturing Practice requirements.

    Product
    Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0849-2016·2016-05-18

    Sesderma Recalls Repaskin 30 Sunscreen for cGMP Deviations

    Sesderma is recalling 27 bottles of Repaskin 30 Facial Sunscreen gel cream because the product does not comply with cGMP requirements.

    Product
    Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0840-2016·2016-05-18

    Mylan Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failures

    Mylan Pharmaceuticals is recalling 2,928 bottles of Paliperidone Extended-Release Tablets, 1.5 mg, because they failed dissolution specifications at a three-month stability time point.

    Product
    Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-3978-93
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0847-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling 195 bottles of Dryses Aluminum Chlorohydrate Deodorant for Women due to cGMP deviations.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0844-2016·2016-05-18

    Sesderma Recalls Repaskin 50 Sunscreen Due to cGMP Deviations

    Sesderma is recalling 15 tubes of Repaskin 50 sunscreen because the product does not comply with current Good Manufacturing Practice (cGMP) requirements.

    Product
    Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0846-2016·2016-05-18

    Sesderma Dryses Deodorant Recalled for cGMP Deviations

    Sesderma is recalling Dryses Aluminum Chlorohydrate Deodorant for Men because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0842-2016·2016-05-18

    Sesderma Recalls Dryses Antiperspirant Solution for cGMP Deviations

    Sesderma is recalling 542 bottles of Dryses Aluminum Chlorohydrate Antiperspirant Solution because the product does not comply with cGMP requirements.

    Product
    Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0852-2016·2016-05-18

    Baxter Recalls Brevibloc Injection Due to Yellow Discoloration

    Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection because the solution shows atypical yellow discoloration. The recall covers 11,630 units distributed nationwide.

    Product
    BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide