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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4676–4700 of 18005

  • SevereFDA (Drugs)·D-0302-2022·2022-01-05

    dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

    SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

    Product
    dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2022·2022-01-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    SterRx is recalling 40 bags of Morphine Sulfate in 5% Dextrose Injection (1 mg per mL) distributed nationwide due to lack of assurance of sterility. The product is subject to contamination risk.

    Product
    Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling 121,584 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The drug is used to treat low blood pressure in critical care settings.

    Product
    NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0317-2022·2022-01-05

    SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance

    SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0316-2022·2022-01-05

    SterRx Fentanyl Citrate Injection Recalled for Sterility Assurance Failure

    SterRx is recalling fentanyl citrate injection nationwide due to lack of assurance of sterility. The recall affects approximately 10,660 bags of the product.

    Product
    Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0321-2022·2022-01-05

    SterRx Norepinephrine 8 mg Sodium Chloride Injection Recalled

    SterRx, LLC is recalling 74,508 bags of Norepinephrine 8 mg per 250 mL in 0.9% Sodium Chloride Injection nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.

    Product
    NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2022·2022-01-05

    SterRx Norepinephrine Injection Recalled Due to Sterility Assurance Concerns

    SterRx is recalling 9,360 bags of Norepinephrine 4 mg per 250 mL injection nationwide due to lack of assurance of sterility. The product is used in hospital and clinical settings to treat low blood pressure.

    Product
    NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure

    SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.

    Product
    PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2022·2022-01-05

    SterRx Succinylcholine Chloride Injection Recalled for Sterility Assurance

    SterRx is recalling Succinylcholine Chloride Injection 20 mg/mL vials (1,000 mL) distributed nationwide due to lack of assurance of sterility. The 3,540 affected bags may pose a risk to patients receiving this injectable drug.

    Product
    Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2022·2022-01-05

    Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

    SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.

    Product
    NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was distributed nationwide.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0297-2022·2022-01-05

    Betamethasone Dipropionate Lotion recalled for failed stability test

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0293-2022·2021-12-29

    OTC Cough and Cold Drug Recalled for Microbial Contamination

    Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.

    Product
    ROMPE PECHO MAX MULTI SYMPTOMS — ROMPE PECHO MAX MULTI SYMPTOMS (ACETAMINOPHEN, DEXTROMETHOPHAN HBR, PHENYLEPHRINE HCL, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2022·2021-12-29

    OTC Expectorant Recall: Microbial Contamination in Rompe Pecho

    Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0288-2022·2021-12-29

    Moxifloxacin 1 mg/mL Solution Label Mix-up Recall

    Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.

    Product
    Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2022·2021-12-29

    Rompe Pecho Cold & Flu Syrup Recalled for Microbial Contamination

    Efficient Laboratories is recalling Rompe Pecho CF Cold & Flu Advanced Formula syrup due to microbial contamination of the non-sterile product. The recall affects 10,833 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0291-2022·2021-12-29

    Rompe Pecho Cough Syrup Recalled for Microbial Contamination

    Efficient Laboratories, Inc. is recalling Rompe Pecho DM cough syrup (6 fl oz bottles) due to microbial contamination of the non-sterile product. The recall affects 27,206 bottles distributed nationwide.

    Product
    ROMPE PECHO — ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0287-2022·2021-12-29

    Medline Hand Sanitizer Foam Recalled for Defective Containers

    Medline Industries Inc is recalling Hand Sanitizer Foam in multiple sizes due to leaking bottles and dispensing issues reported by customers. The product was distributed nationwide and internationally.

    Product
    Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0289-2022·2021-12-29

    Fexofenadine Hydrochloride Tablets 60 mg Recalled for Failed Impurities and Degradation Specifications

    The Harvard Drug Group is recalling Fexofenadine Hydrochloride Tablets, 60 mg, distributed by Major Pharmaceuticals nationwide due to failed impurities and degradation specifications. Affected lots are H00005, H00006, and H00007.

    Product
    Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0294-2022·2021-12-29

    Penicillin V Potassium Oral Solution recalled for subpotency

    Teva Pharmaceuticals USA is recalling certain lots of Penicillin V Potassium for Oral Solution nationwide because the medication is subpotent—containing less active ingredient than labeled. The recall affects 100 mL and 200 mL bottles distributed nationwide.

    Product
    Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0358-2022·2021-12-22

    Livia One Organic Daily Topical Spray Probiotics recalled for Pseudomonas contamination

    Livia Global is recalling Livia One Organic Daily Topical Spray Probiotics because the product may be contaminated with Pseudomonas aeruginosa, a bacterium that can cause infection.

    Product
    Livia One Organic Daily Topical Spray Probiotics; 4 oz. (120 ml) UPC: 0 30915 10710 5 Recommended use: Topical: Spray affected area 2-5 times daily as needed. Ingredients: Proprietary probiotic blend in an enzyme enriched substrate: Lactobacillus-Acidophilus, L. Rhamn
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0280-2022·2021-12-22

    Lidocaine Topical Solution Recalled for Superpotency

    Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0359-2022·2021-12-22

    Livia One Organic Probiotic Nasal Spray Recalled for Pseudomonas Contamination

    Livia Global is recalling Livia One Organic Probiotic Nasal Spray due to contamination with Pseudomonas aeruginosa, a bacterium that can cause respiratory infection.

    Product
    Livia One Organic Probiotic Nasal Spray; 1 oz. (30 ml) UPC: 0 30915 10719 8 Suggested use: Adult - 102 pumps in each nostril as needed 1-3 times per day; Children 4-12 years : 1/4-1/2 pump in each nostril as needed - 103 times daily as needed. Children 3 and under: It is
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0278-2022·2021-12-22

    Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

    Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0279-2022·2021-12-22

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide