The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

2476–2500 of 2769

  • LowFDA (Devices)·Z-1258-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Straight Rods

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1264-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1246-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System lordosed rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1254-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-318-2013·2013-05-15

    Liothyronine Sodium Tablets Recalled for Failed Stability Testing

    L. Perrigo Co. is recalling Liothyronine Sodium Tablets, 5 mcg, because they failed 3-month stability testing specifications.

    Product
    Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1250-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1249-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod due to a raw material issue.

    Product
    Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1252-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System Lordosed Rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1266-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1251-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected products were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1265-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System straight rod due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1256-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of the Mercury Spinal System DIA 5.5 x 30mm Straight Rod due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-310-2013·2013-05-08

    Reckitt Benckiser Recalls Cherry Cepacol Sore Throat Lozenges for Low Benzocaine

    Reckitt Benckiser is recalling Cherry Cepacol Sore Throat Lozenges because the active ingredient, benzocaine, did not meet stability specifications.

    Product
    Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1360-2013·2013-05-08

    Pina Colada Dessert Bar Recalled for Undeclared Food Dye

    Paleteria Y Neveria La Rosita, LLC is recalling Pina Colada Dessert Bars because the product contains undeclared FD&C Red #40.

    Product
    Pina Colada Dessert Bar , 4 oz. Undeclared FD&C Red # 40 in clear flexible plastic, ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, cream of coconut, whey powder,
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1361-2013·2013-05-08

    Strawberry Milk Dessert Bar Recalled for Undeclared FD&C Blue # 1

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Milk Dessert Bars sold in Michigan and Indiana due to undeclared FD&C Blue # 1.

    Product
    Strawberry Milk Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, sugar, partially hydrogenated palm kernel oil, nonfat milk solids, red 40, UPC Code 8 94163 00220 5
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-1364-2013·2013-05-08

    Strawberry Eskimo Dessert Bar Recalled for Undeclared FD&C Blue # 1

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Eskimo Dessert Bars because the product contains undeclared FD&C Blue # 1.

    Product
    Strawberry Eskimo Dessert Bar , 4 oz. Undeclared FD&C Blue # 1 packaged in clear flexible plastic, ingredients: water, chocolate coating (coconut oil, sugar, partially hydrogenated coconut and soybean oil, cocoa, corn starch, soy lecithin, etc.) red 40, UPC Code 8 94163 00230 4
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-301-2013·2013-05-08

    Percocet 10/325 mg Tablets Recalled Due to Foreign Tablet Presence

    Physicians Total Care is recalling one bottle of Percocet 10/325 mg tablets because it contained a foreign Endocet 10/25 mg tablet.

    Product
    Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis Consumer Health I, Lincoln, NE 68581; NDC 54868-4710-0, Barcode 47101006IHD.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-305-2013·2013-05-08

    Warner Chilcott Recalls Femhrt Tablets Due to Chemical Contamination

    Warner Chilcott is recalling 6,408 bottles of Femhrt tablets because 2-phenylphenol was found in the product. The chemical migrated from the cardboard cartons used for packaging.

    Product
    Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle ( NDC#: 0430-0544-23), Rx only, Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738, Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1362-2013·2013-05-08

    Bubble Gum Frozen Dessert Bar Recalled for Undeclared Red Dye

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Bubble Gum Frozen Dessert Bars because the product contains undeclared FD&C Red # 3.

    Product
    Bubble Gum Frozen Dessert Bar , 4 oz. Undeclared FD&C Red # 3 packaged in clear flexible plastic, ingredients: water, sugar, citric acid, blue 1 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • LowFDA (Drugs)·D-302-2013·2013-05-08

    Hi-Tech Pharmacal Recalls Subpotent Acetic Acid Otic Solution

    Hi-Tech Pharmacal is recalling 11,472 bottles of Acetic Acid Otic Solution because the product failed potency testing. The recall covers nationwide distribution and Puerto Rico.

    Product
    Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1363-2013·2013-05-08

    Strawberry Fruit Bar Recalled for Undeclared FD&C Blue # 1 Ingredient

    Paleteria Y Neveria La Rosita, LLC is recalling 4 oz. Strawberry Fruit Bars sold in Michigan and Indiana because the product contains undeclared FD&C Blue # 1.

    Product
    Strawberry Fruit Bar , 4 oz. Undeclared FD&C Blue # 1 ingredients: water, strawberries, sugar, citric acid, red 40 UPC Code 8 94163 00210 6
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1161-2013·2013-05-01

    Ortho-Clinical Diagnostics Recalls Vitros Anti-HBs Reagent Packs Due to Calibration Failure

    Ortho-Clinical Diagnostics is recalling specific lots of Vitros Anti-HBs Reagent Packs because they may fail to obtain a valid calibration.

    Product
    VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-269-2013·2013-05-01

    Mylan Recalls Lisinopril Tablets With Incorrect Identifier Codes

    Mylan Pharmaceuticals is recalling 2,405 bottles of Lisinopril 10 mg tablets because the pills have the wrong ID code imprinted on them.

    Product
    Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1338-2013·2013-05-01

    Nexgen Pharma Recalls L-Arginine Supplement Due to Subpotency

    Nexgen Pharma is recalling a specific lot of L-Arginine L-Ornithine Alpha Lipoic Acid capsules because the Alpha Lipoic Acid ingredient is subpotent.

    Product
    Free Form Amino Acids L-Arginine 7 L-Ornithine Complex With Alpha-Lipoic Acid, Promotes Circulation and Muscle Development, Dietary Supplement, 50 Vegetarian Capsules, Gluten Free, Serving Size 2 Capsules. Each product is produced for a specific customer with their distribution
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2013·2013-05-01

    Sirtex SIR-yttrium 90 microspheres recalled for incorrect expiration date

    Sirtex Medical Limited is recalling 21 doses of SIR-yttrium 90 microspheres due to an incorrect expiration date. The product is used to treat unresectable metastatic liver tumors.

    Product
    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide