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 2769

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 (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 mon
Category
Medical Device
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, vinegar
Category
Food
Distribution
10 states
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
LowFDA (Drugs)·D-1039-2017·2017-08-09
Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.
Product
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Category
Drug
Distribution
Distributed nationwide
LowUSDA FSIS·090-2017·2017-08-09
Corn Maiden Foods Recalls Ready-to-Eat Beef Pies Due to Misbranding
Corn Maiden Foods is recalling ready-to-eat beef pies because they contain undeclared monosodium glutamate (MSG). No adverse reactions have been reported.
Product
Corn Maiden Foods, Inc. — Corn Maiden Foods, Inc. Recalls Ready-to-Eat Beef Products Due To Misbranding
Category
Food
Distribution
1 state
LowFDA (Devices)·Z-2756-2017·2017-08-02
PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers did not match the devices inside.
Product
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2759-2017·2017-08-02
Smiths Medical CADD IV Administration Set Recalled for Missing Expiration Date
Smiths Medical ASD Inc. is recalling CADD Blue-Striped IV Administration Sets in Canada because the labels are missing expiration dates.
Product
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Category
Medical Device
Distribution
0 states