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.

326–350 of 2766

LowFDA (Devices)·Z-2375-2021·2021-09-08
Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0785-2021·2021-09-08
Lidocaine Ointment USP 5% Recalled for Failed Viscosity Specifications
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
Product
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2363-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Product
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0784-2021·2021-09-08
Donepezil HCL Tablets 5 mg Recalled for Subpotency
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
Product
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0929-2021·2021-09-08
Frozen Cheesecake and Torte Products Mislabeled with Incorrect Ingredients
Gem City Fine Foods is recalling frozen desserts with mismatched ingredient and nutrition labels, and with false pecan labeling despite no nuts being used since April 2018.
Product
Triple Berry Streusel Cheesecake, 20 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001193. Store Frozen or Thawed in Fridge.
Category
Food
Distribution
2 states
LowFDA (Devices)·Z-2374-2021·2021-09-08
Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
Product
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0771-2021·2021-09-01
Bleomycin for Injection Recalled Due to Mislabeling
Hikma Pharmaceuticals USA Inc. is recalling Bleomycin for Injection, USP due to mislabeling. The recall affects 1,152 vials distributed nationwide.
Product
BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0870-2021·2021-08-25
Cotton Blues Cheesecake Strawberry Swirl recalled for incorrect ingredient labeling
CB Distribution LLC is recalling Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice packages due to incorrect ingredient labeling. The product was distributed to distribution centers in Texas.
Product
Cotton Blues Cheesecake Co. Strawberry Swirl Single Slice 6oz plastic container 36 packages per case
Category
Food
Distribution
1 state
LowFDA (Food)·F-0859-2021·2021-08-18
Wickles Relish 16oz Glass Jars Recalled for Wrong Label
Magnolia Vegetable Processors is recalling Wickles Relish 16oz glass jars (Lot No. 2001210406) due to an incorrect label applied to the product. The affected cases were distributed to eight states.
Product
Wickles Relish 16oz glass jars - 6 jars per case
Category
Food
Distribution
8 states
LowFDA (Food)·F-0789-2021·2021-07-28
Kroger Vitamin D3 Softgels May Contain Undeclared Coq10
Bountiful Trading Inc is recalling Kroger brand Vitamin D3 125 mcg softgels because they may contain undeclared Coq10. Consumers with allergies or sensitivities to Coq10 are at risk.
Product
Kroger brand, Vitamin D3 125 mcg softgels, 100 count, Green HDPE packaging
Category
Food
Distribution
5 states
LowFDA (Drugs)·D-0665-2021·2021-07-28
Acetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling
LNK International is recalling Acetaminophen Extra Strength coated tablets because the primary label incorrectly states "enteric coated" when the tablets are not enteric coated and should be labeled as standard coated tablets.
Product
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0655-2021·2021-07-21
LEUKINE (Sargramostim) Injection Recalled for Failed Stability Specification
Partner Therapeutics Inc is recalling LEUKINE (sargramostim) for injection due to an out-of-specification result observed at the 27-month stability timepoint. The recall affects 32,260 vials distributed to one government account.
Product
LEUKINE — LEUKINE (SARGRAMOSTIM)
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0639-2021·2021-06-30
Phytonadione 5 mg Tablets Recalled for Failed Impurity Specifications
Bausch Health Companies is recalling Phytonadione 5 mg tablets distributed nationwide because the affected lots failed to meet impurity and degradation specifications. Consumers should consult their healthcare provider before stopping this medication.
Product
Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0665-2021·2021-06-23
BTREX PLUS Dietary Supplement Recalled for Damaged Tablets
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS Dietary Supplement (100 caplets, UPC 05380930801, Lot #30636, Exp. 01/2022) due to the presence of damaged tablets resulting from manufacturing deviations.
Product
BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801
Category
Food
Distribution
1 state
LowFDA (Food)·F-0666-2021·2021-06-23
BTREX PLUS Dietary Supplement Recalled for Damaged Tablets
Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement 2-caplet bottles (Lot #30637, expiration 01.2022) due to the presence of damaged tablets resulting from Current Good Manufacturing Practice (CGMP) deviations.
Product
BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples)
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0606-2021·2021-06-16
DELFELX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse
Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.
Product
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0608-2021·2021-06-16
DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.
Product
DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1828-2021·2021-06-16
VIA Microcatheter recalled due to incorrect international labeling shipped to US
MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.
Product
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0607-2021·2021-06-16
DELFLEX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse
Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.
Product
DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0601-2021·2021-06-09
Thiamine HCl Injection Recall: Vials with Incorrect Lot Numbers
Mylan Institutional LLC is recalling Thiamine Hydrochloride Injection USP 200 mg/2 mL due to vials labeled with incorrect lot numbers. The cartons contain the correct lot number 200906 but vials inside are labeled with lot number 200901.
Product
THIAMINE HYDROCHLORIDE — THIAMINE HYDROCHLORIDE (THIAMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0630-2021·2021-06-02
Dole Peach Slices Recalled for Incorrect Labeling
Dole is recalling 2,120 cases of Yellow cling Peach Slices because the lid label incorrectly identifies the contents as Mixed Fruit.
Product
Dole Yellow cling Peach Slices in 100% Fruit Juice. Snack & Store Fridge Pack. Net Wt 15 oz. (425g). UPC 38900-00642. Manufactured for Dole Packaged Foods, LLC, Westlake Village, CA 91361. Packed in Thailand.
Category
Food
Distribution
8 states
LowFDA (Drugs)·D-0599-2021·2021-06-02
Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets due to the presence of degradation impurities.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0392-2021·2021-06-02
Ascend Recalls Olmesartan Medoxomil Tablets Due to Foreign Tablet Presence
Ascend Laboratories LLC is recalling 34,296 bottles of Olmesartan Medoxomil 20 mg tablets because they may contain a foreign tablet or capsule.
Product
OLMESARTAN MEDOXOMIL — OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0379-2021·2021-05-26
SigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
SigmaPharm Laboratories is recalling Asenapine sublingual tablets because they were manufactured with the wrong flavoring agent.
Product
ASENAPINE — ASENAPINE (ASENAPINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0380-2021·2021-05-26
SigmaPharm Recalls Asenapine Tablets Due to Incorrect Flavoring Agent
SigmaPharm Laboratories LLC is recalling Asenapine Sublingual Tablets because they were manufactured with the incorrect flavoring agent.
Product
ASENAPINE — ASENAPINE (ASENAPINE)
Category
Drug
Distribution
Distributed nationwide