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.

1201–1225 of 2741

  • LowFDA (Drugs)·D-1139-2017·2017-09-20

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Labeling Error

    VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the product was incorrectly labeled as a Class III controlled substance instead of a Class II controlled substance.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3132-2017·2017-09-20

    Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records

    Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.

    Product
    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-3128-2017·2017-09-20

    Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection

    Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.

    Product
    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1162-2017·2017-09-20

    Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures

    Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-1128-2017·2017-09-13

    McKesson Recalls Propafenone Hydrochloride Tablets for Moisture Content Issues

    McKesson Packaging Services is recalling Propafenone Hydrochloride tablets due to failed moisture limits. The affected units were distributed to five states.

    Product
    Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-1127-2017·2017-09-13

    Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-3484-2107·2017-09-06

    Mary's Gone Crackers Recalled for Blue Plastic Liner Fragments

    Mary's Gone Crackers is recalling Original Crackers because pieces of blue grade plastic liner were found inside the packaged product.

    Product
    Mary's Gone Crackers Original Crackers: Organic, Gluten Free, Non-GMO, Vegan. 6.5 oz. (184 g) box; Ingredients: Whole grain brown rice, whole grain quinoa, brown flax seeds, brown sesame seeds, filtered water, sea salt, wheat free tamari (water, whole soybeans, salt…
    Category
    Food
    Distribution
    10 states
  • LowFDA (Devices)·Z-3084-2017·2017-09-06

    Alere iScreen Dx Urine Drug Screen Card Recalled for Labeling Error

    Ameditech Inc is recalling Alere iScreen Dx Urine Drug Screen Cards because the kit box label incorrectly identifies PCP instead of TCA as a drug analyte.

    Product
    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1097-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Moisturizing Balm Due to SPF Labeling Concerns

    Linde Eckstein is recalling 478 bottles of Beautipharm All Day Moisturizing Balm SPF 10 because the SPF 10 protection claim cannot be fully guaranteed.

    Product
    Beautipharm All Day Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Facial Cream, 1.66 oz. Net. Wt. 50 ml bottle, Art. 03120 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 032005.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1101-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed. The product was distributed throughout the United States.

    Product
    Make Up Transparent pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03210, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032104.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1104-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Concerns

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

    Product
    Make Up Transparent dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03240, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032401.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1107-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Sun Protection

    Linde Eckstein is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed. Consumers should stop using the product.

    Product
    Make Up Perfect pastel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03310, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033101.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1103-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect Caramel SPF 10 Liquid Make-Up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect Caramel SPF 10 liquid make-up because the SPF 10 protection claim cannot be fully guaranteed.

    Product
    Make Up Perfect caramel (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03330, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032302.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1105-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein Gmbh + Co KG is recalling SPF 10 liquid make-up because the sun protection claim cannot be fully guaranteed.

    Product
    Make Up Transparent terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03250, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032500.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1090-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1106-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect Ivory SPF 10 Liquid Make-Up

    Linde Eckstein is recalling Make Up Perfect Ivory SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03300, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033002.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1083-2017·2017-08-23

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride capsules because they failed impurity specifications during stability testing.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1109-2017·2017-08-23

    Linde Eckstein Recalls Make Up Perfect SPF 10 Liquid Make-up

    Linde Eckstein Gmbh + Co KG is recalling Make Up Perfect dark tan SPF 10 liquid make-up because the SPF 10 protection claim cannot be guaranteed.

    Product
    Make Up Perfect dark tan (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03340, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033408.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1110-2017·2017-08-23

    Linde Eckstein Recalls SPF 10 Liquid Make-Up Due to Subpotent Labeling

    Linde Eckstein is recalling Make Up Perfect terra SPF 10 liquid make-up because the sun protection factor claim cannot be fully guaranteed.

    Product
    Make Up Perfect terra (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03350, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 033507.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1100-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Claims

    Linde Eckstein is recalling 373 bottles of SPF 10 liquid make-up because the sun protection claim cannot be guaranteed.

    Product
    Make Up Transparent ivory (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03200, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032005.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1098-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Body Moisturizing Balm Due to Subpotent SPF

    Linde Eckstein is recalling Beautipharm Body Moisturizing Balm SPF 10 because the sun protection factor claim cannot be fully guaranteed.

    Product
    Beautipharm Body Moisturizing Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Body Lotion, 8.3 oz. Net. Wt. 250 ml bottle, Art. 03150 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031503.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1099-2017·2017-08-23

    Linde Eckstein Recalls Beautipharm Eye Care Balm Due to SPF Labeling Concerns

    Linde Eckstein is recalling 73 bottles of Beautipharm Eye Care Balm SPF 10 because the sun protection factor claim cannot be fully guaranteed.

    Product
    Beautipharm Eye Care Balm SPF 10 (Octocrylene 4% and Octyl methoxycinnamide 4%) Eye cream, 1 oz. Net. Wt. 30 ml bottle, Art. 03190 Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany. UPC 4 035219 031909.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1089-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1102-2017·2017-08-23

    Linde Eckstein SPF 10 Liquid Make-up Recalled for Subpotent Drug Claim

    Linde Eckstein is recalling specific lots of SPF 10 liquid make-up because the sun protection factor claim cannot be fully guaranteed.

    Product
    Make Up Transparent sand (Titanium Dioxide) SPF 10 liquid make-up, 1 oz. Net Wt. 30 ml bottle, Art. 03220, Made in Germany, Doctor Eckstein, Linde Eckstein GMBH Co. Kg, 90522 Oberasbach, Germany, UPC 4 035219 032203.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1058-2017·2017-08-16

    Teva Recalls Glipizide Extended-Release Tablets Due to Moisture Limit Failures

    Teva Pharmaceuticals USA is recalling 2,880 cartons of Glipizide Extended-Release Tablets, 5 mg, because stability testing revealed out-of-specification water content.

    Product
    Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
    Category
    Drug
    Distribution
    6 states