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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13951–13975 of 18001

  • HighFDA (Drugs)·D-1031-2015·2015-05-20

    Spironolactone Suspension Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Spironolactone 5 mg/mL Suspension due to quality control issues affecting sterility and stability data.

    Product
    Spironolactone 5 mg/mL Susp, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1014-2015·2015-05-20

    Health Innovations Pharmacy Recalls Estriol 5% Cream Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Estriol 5% Cream Vaginal Cream because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    Estriol 5% Cream Vaginal Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1010-2015·2015-05-20

    Health Innovations Pharmacy Recalls Phospholine Iodide Eye Drops

    Health Innovations Pharmacy is recalling Phospholine Iodide 0.03% Opth Drops due to quality control issues affecting sterility and stability.

    Product
    Phospholine Iodide 0.03% Opth Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1020-2015·2015-05-20

    Pregnenolone 20 mg SR Capsules Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling all lots of Pregnenolone 20 mg SR Capsules due to quality control issues affecting sterility and stability.

    Product
    Pregnenolone 20 mg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1022-2015·2015-05-20

    Health Innovations Pharmacy Recalls Keto-Gabap-Ketamine Cream Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Keto 10%-Gabap 10%-Ketamine 2% Cream because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    Keto 10%-Gabap 10%-Ketamine 2% Cream, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1036-2015·2015-05-20

    Levodopa 250 mg Capsules Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Levodopa 250 mg NSR Capsules due to quality control issues affecting sterility and stability data.

    Product
    Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1082-2015·2015-05-20

    Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Test

    Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed a dissolution specification test.

    Product
    NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE — NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0995-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1032-2015·2015-05-20

    Carvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns

    Health Innovations Pharmacy is recalling Carvedilol 1.25 mg/mL due to quality control issues affecting sterility and stability data.

    Product
    Carvedilol 1.25 mg/mL, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0996-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1080-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 6,467 units of Olanzapine 10 mg orally disintegrating tablets because the drug is subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1057-2015·2015-05-20

    Health Innovations Pharmacy Recalls Colchicine Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Colchicine 0.6 mg capsules because inspection observations indicate a lack of assurance regarding sterility and stability data.

    Product
    Colchicine 0.6 mg Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1045-2015·2015-05-20

    Health Innovations Pharmacy Recalls Nifedipine and Lidocaine Jelly

    Health Innovations Pharmacy is recalling Nifedipine 0.2% - Lidocaine 2% Jelly due to sterility and stability concerns. The recall covers all lots distributed in North Carolina.

    Product
    Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0997-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1065-2015·2015-05-20

    Mission Pharmacal Recalls Sodium Sulfacetamide and Sulfur Wash Kits

    Mission Pharmacal is recalling 1,992 kits of Sodium Sulfacetamide 9% and Sulfur 4.5% Wash due to microbial contamination.

    Product
    Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1019-2015·2015-05-20

    Health Innovations Pharmacy Recalls DHEA Capsules Due to Sterility Concerns

    Health Innovations Pharmacy is recalling DHEA 10 mg SR Capsules because inspection findings indicate a lack of assurance regarding sterility and stability data.

    Product
    DHEA 10 mg SR Caps, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1048-2015·2015-05-20

    Health Innovations Pharmacy Recalls Phenylephrine Solution Due to Sterility Concerns

    Health Innovations Pharmacy is recalling Phenylephrine 0.5% Solution due to quality control issues that present a risk to sterility and stability.

    Product
    Phenylephrine 0.5% Solution (Bottle), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1078-2015·2015-05-20

    Cipla Recalls Levalbuterol Inhalation Solution Vials for Impurity Failure

    Cipla Limited is recalling 140,625 vials of Levalbuterol Inhalation Solution because the product failed impurity specifications. The affected lot is distributed nationwide.

    Product
    Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1077-2015·2015-05-20

    FDA Recalls Monistat 1 Simple Cure for Missing Topical Cream

    Medtech Products, Inc. is recalling Monistat 1 Simple Cure because the distributed units lack the required topical cream.

    Product
    MONISTAT 1 COMBINATION PACK — MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1079-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling specific lots of Olanzapine 5 mg orally disintegrating tablets because they contain less active drug than labeled.

    Product
    Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1081-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine 20 mg tablets because the drug was found to be subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0982-2015·2015-05-13

    Physician Preferred Medical Recalls Epel 18 mg Estradiol Pellets Due to Sterility Failure

    Physician Preferred Medical, LLC is recalling Epel 18 mg Estradiol Pellets because the specific lot failed sterility testing. The product was distributed in Arizona and Kansas.

    Product
    Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0977-2015·2015-05-13

    FDA Recalls EDGE Weight Release Capsules Containing Unapproved Drugs

    Detox Transforms is recalling EDGE Amplified Weight Release capsules because the product contains undeclared phenolphthalein and fluoxetine, making it an unapproved drug.

    Product
    EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00417 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0991-2015·2015-05-13

    Ultra ZX Dietary Supplement Recalled for Undeclared Sibutramine and Phenolphthalein

    Ultra ZX Labs is recalling Ultra ZX dietary supplements because FDA testing found undeclared sibutramine and phenolphthalein. The product was marketed without an approved NDA or ANDA.

    Product
    ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0981-2015·2015-05-13

    FDA Recalls iNSANE Bee Pollen Capsules Containing Unapproved Drugs

    The FDA is recalling iNSANE Bee Pollen capsules because they contain undeclared phenolphthalein and fluoxetine, making them unapproved drugs.

    Product
    iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
    Category
    Drug
    Distribution
    Distributed nationwide