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.

251–261 of 261

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 (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-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-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-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-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