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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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17951–17975 of 18050

  • SevereFDA (Drugs)·D-1580-2012·2012-08-22

    Franck's Lab Recalls Sterile Midazolam Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile midazolam injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML; MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML; MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1486-2012·2012-08-22

    Franck's Lab Recalls Sterile Clindamycin Eye and Injectable Products

    Franck's Lab Inc. is recalling sterile clindamycin eye and injectable products due to microorganisms and fungal growth found in the clean room.

    Product
    CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABLE 0.2 ML; CLINDAMYCIN PHOSPHATE SDPF- (0.1ML SYRINGE,30G,1/2") 1MG/0.1ML INJECTABLE 0.1 ML (3 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1611-2012·2012-08-22

    Franck's Lab Recalls Ranibizumab Injectable Due to Sterility Concerns

    Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.

    Product
    RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1558-2012·2012-08-22

    Franck's Lab Recalls Sterile Lidocaine Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile lidocaine products distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; LIDOCAINE HCL 1% INJECTABLE 100 ML 1000 ML 1200 ML 1250 ML…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1597-2012·2012-08-22

    Phentolamine Injectable Recall Due to Sterility Assurance Failure

    Franck's Lab Inc. is recalling Phentolamine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    PHENTOLAMINE 10MG/ML INJECTABLE 6 ML; PHENTOLAMINE 1MG/ML INJECTABLE 2 ML 5 ML; PHENTOLAMINE 5MG/ML INJECTABLE 20 ML 50 ML (5 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1482-2012·2012-08-22

    Franck's Lab Recalls Sterile Ceftazidime Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling sterile Ceftazidime ophthalmic products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.

    Product
    CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT 1 KIT…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1545-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Solutions Due to Contamination

    Franck's Lab Inc. is recalling sterile injectable solutions because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

    Product
    HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1554-2012·2012-08-22

    Franck's Lab Recalls Sterile L-Arginine Injectable Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile L-Arginine 500mg/mL injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.

    Product
    L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1530-2012·2012-08-22

    Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns

    Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.

    Product
    GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1569-2012·2012-08-22

    Franck's Lab Recalls Sterile Mannitol Injectable Drugs Due to Contamination

    Franck's Lab Inc. is recalling sterile Mannitol injectable drugs because FDA testing found microorganisms and fungal growth in the manufacturing clean room.

    Product
    MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML 400 ML 600 ML (9 DIFFERENT PRODUCTS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1603-2012·2012-08-22

    Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination

    Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.

    Product
    POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1646-2012·2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

    Hill Dermaceuticals is recalling 161,064 bottles of Derma-Smoothe/FS scalp oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1645-2012·2012-08-22

    Topiramate Tablets Recalled for Incorrect Labeling of Product Form

    American Health Packaging is recalling Topiramate Tablets due to a labeling error that incorrectly identifies the product as capsules.

    Product
    Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1647-2012·2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Body Oil

    Hill Dermaceuticals is recalling 111,816 bottles of Derma-Smoothe/FS Body Oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1444-2012·2012-08-15

    Hospira Recalls Overfilled Hydromorphone Hydrochloride Prefilled Cartridges

    Hospira Inc. is recalling 223,750 units of Hydromorphone Hydrochloride Injection because some prefilled cartridges contain more than the labeled 1 mL volume.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1446-2012·2012-08-15

    Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because the company cannot ensure the product is sterile. The recall affects 56,028 cartons distributed nationwide and in Puerto Rico.

    Product
    ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1442-2012·2012-08-15

    Teva Recalls Copaxone Injections Due to Foreign Particle Presence

    Teva Pharmaceuticals is recalling specific lots of Copaxone (glatiramer acetate) injection due to the presence of a foreign particle identified from a customer complaint.

    Product
    COPAXONE — COPAXONE (GLATIRAMER ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1443-2012·2012-08-15

    Apotex Recalls Meloxicam Tablets Due to Slightly Oversized Tablet

    Apotex Corp. is recalling 1,749 bottles of Meloxicam 15 mg tablets because one bottle contained a slightly oversized tablet.

    Product
    Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1445-2012·2012-08-15

    Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Testing Failures

    Oklahoma Respiratory Care Inc is recalling 861 cylinders of compressed oxygen due to missing identity and purity testing and documentation gaps.

    Product
    OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1440-2012·2012-08-08

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1429-2012·2012-08-08

    Eagle Pharmaceuticals Recalls Argatroban Injection Due to Visible Particulates

    Eagle Pharmaceuticals is recalling specific lots of Argatroban Injection after a hospital reported crystalline particulates and fibers in a vial.

    Product
    Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ…
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1435-2012·2012-08-08

    Dr. Reddy's Ciprofloxacin Tablets Recalled for Foreign Tablet Contamination

    Dr. Reddy's is recalling Ciprofloxacin Tablets due to complaints of mislabeled bottles containing foreign tablets.

    Product
    Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2012·2012-08-08

    Bayer Recalls Estradiol Hemihydrate Powder Due to Cross Contamination

    Bayer HealthCare Pharmaceuticals is recalling Estradiol Hemihydrate M20 EP/USP Powder due to cross contamination with another product. The affected lot was distributed in Kansas and California.

    Product
    Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1434-2012·2012-08-08

    Dr. Reddy's Recalls Amlodipine and Benazepril Capsules Due to Foreign Tablets

    Dr. Reddy's is recalling Amlodipine Besylate and Benazepril Hydrochloride capsules because bottles were mislabeled and contained foreign Ciprofloxacin tablets.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide