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.

276–300 of 2766

LowFDA (Food)·F-1344-2022·2022-06-29
Pedialyte Immune Support Raspberry Lemonade recalled for container leakage risk
Abbott Laboratories is recalling approximately 121,918 cases of Pedialyte with Immune Support Raspberry Lemonade due to potential container leakage. The recall affects multiple states.
Product
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemonade Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT) 1L*** INGREDIENTS: WATER, DEXTROSE***Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219-3034 USA
Category
Food
Distribution
28 states
LowFDA (Devices)·Z-1125-2022·2022-06-01
Medical device labeling error: KWIK-STIK® plus Clostridium perfringens
Microbiologics Inc recalled 8 units of KWIK-STIK® plus Clostridium perfringens due to a labeling error. The affected lot (801-44-4) was distributed to laboratories in the United States and internationally.
Product
KWIK-STIK" plus: Clostridium perfringens
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0879-2022·2022-05-25
Open Nature Cough Drops recalled due to subpotent menthol content
Bestco LLC is recalling Open Nature Cough Drops (Menthol flavor) due to insufficient menthol content. Products may not be effective as labeled.
Product
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
Category
Drug
Distribution
4 states
LowFDA (Devices)·Z-1056-2022·2022-05-18
Bone Graft Syringe Recall: Patient Chart Labels List Incorrect Part Numbers
Cerapedics is recalling putty i-FACTOR Peptide Enhanced Bone Graft syringes because patient chart labels contain incorrect Part Numbers and volume amounts. The company discovered the labeling discrepancy in 572 units distributed nationwide.
Product
putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTY
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0901-2022·2022-04-20
IntraSight Mobile IVUS touch screen modules missing required labeling information
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
Product
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Category
Medical Device
Distribution
15 states
LowFDA (Devices)·Z-0876-2022·2022-04-13
Cook Celect Platinum Vena Cava Filter Set Instructions Recall
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets due to revisions needed in the instructions for use, including updates to contraindications, warnings, precautions, and potential adverse events.
Product
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-0903-2022·2022-03-30
Bison Breakfast Meal Recalled for Unspecified Fish Allergen
HumbleHungryHappy LLC recalls 97 containers of Bison Breakfast due to incomplete allergen labeling: the product declares Fish but does not specify which fish. Consumers with fish allergies may not have adequate warning.
Product
Bison Breakfast, packaged meal, net wt. 11.5oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is read in parts: "**
Category
Food
Distribution
1 state
LowFDA (Food)·F-0905-2022·2022-03-30
Marine Corps Mash packaged meal recall for incomplete fish allergen labeling
HumbleHungryHappy LLC is recalling Marine Corps Mash packaged meals (9.8 oz and 13.8 oz) distributed in Oregon and online because the product declares fish as an allergen but does not specify the type of fish.
Product
Marine Corps Mash, packaged meal, net wt. 9.8 oz and 13.8 oz. Product is fully cooked, refrigerated, and to-be-reheated by consumers for immediate consumption. Product is packaged in a rectangular flexible plastic clamshell covered with plastic film lid. Product label is rea
Category
Food
Distribution
1 state
LowFDA (Drugs)·D-0723-2022·2022-03-30
Hydroxocobalamin B12 Injection Recalled for Sub-Potent Dose
Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1mg/mL injection vials distributed nationwide because the product is sub-potent (below specified strength). The firm initiated this voluntary recall on March 8, 2022.
Product
Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0801-2022·2022-03-23
Medical dressing recall issued due to incorrect instructions for use
CellEra LLC recalls Vitale Silver calcium Alginate Dressing Ropes due to incorrect Instructions for Use in product packaging. The manufacturer is replacing affected units with corrected instructions.
Product
20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0803-2022·2022-03-23
Medical device wound dressing recall for incorrect instructions
CellEra LLC is recalling Vitale Silver calcium Alginate Dressings because product packages contain incorrect Instructions for Use with language beyond FDA 510(k) clearance scope. The firm is replacing affected units with correct instructions.
Product
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0804-2022·2022-03-23
Calcium alginate wound dressings recalled for incorrect instruction labeling
CellEra LLC is recalling Vitale Silver calcium alginate dressings because the included Instructions for Use contain language exceeding FDA clearance. The firm is replacing affected units with correct instructions.
Product
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2022·2022-03-16
HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads
Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.
Product
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0569-2022·2022-03-02
Norepinephrine Bitartrate IV Bags Recalled for Subpotency
BayCare Central Pharmacy is recalling 1,157 bags of norepinephrine bitartrate 16 mg in 250 mL saline solution distributed in Florida because the drug is subpotent—meaning it contains less active ingredient than labeled.
Product
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
Category
Drug
Distribution
1 state
LowFDA (Devices)·Z-0641-2022·2022-02-23
Microbiology quality control kit recalled for incorrect inner label
A KWIK-STIK quality control kit has an incorrect inner label. The product contains Campylobacter coli, but the inner label states Haemophilus influenzae.
Product
KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0581-2022·2022-02-16
Medical device lot number misprinted on packaging
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0543-2022·2022-02-09
Microbiologics KWIK-STIK Candida Parapsilosis Control Has Incorrect Pouch Labeling
Microbiologics is recalling KWIK-STIK Candida parapsilosis diagnostic controls with lot 726-57-10 because some pouches are labeled with incorrect catalog number (323-108-7 instead of 0726P).
Product
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states
LowFDA (Drugs)·D-0522-2022·2022-02-09
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling. The recall affects 6,430 cartons distributed throughout the USA.
Product
MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0521-2022·2022-02-09
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
Teva Pharmaceuticals USA is recalling Mimvey (estradiol and norethindrone acetate) tablets nationwide due to mislabeling on certain cartons. The recall affects 218,174 cartons distributed in the United States.
Product
MIMVEY — MIMVEY (ESTRADIOL AND NORETHINDRONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0453-2022·2022-02-02
CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content
CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.
Product
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0379-2022·2022-01-26
Rugby Antihistamine and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Rugby brand antihistamine and nasal decongestant tablets nationwide due to failed dissolution specifications. The affected product is NDC 0536-1242-07, Lot #AC2106452F with expiration date 3/31/2023.
Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0378-2022·2022-01-26
Wal-Fex D Allergy and Decongestant Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Wal-Fex D Extended Release Tablets nationwide due to failed dissolution specifications. The affected product combines fexofenadine (antihistamine) and pseudoephedrine (decongestant).
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0507-2022·2022-01-26
Fish-Pickle Product Recalled for Incomplete Fish Species Labeling
Aroma Meats LLC has recalled Fish-Pickle packaged in yellow plastic pouches distributed in Oregon because the specific type of fish used is not declared on the label, contrary to regulatory requirements.
Product
Fish-Pickle is packaged in yellow plastic pouch. No listed weight, no UPC. Product is imported from Jampani Foods SRT 252 Sanathnagar, Hyderabad-500018. The label is read in parts: "***Fish-Pickle ***Ingredients: Raw Fish, Ginger Garlic Paste, Turmeric Powder, Chilli Powder, S
Category
Food
Distribution
1 state
LowFDA (Drugs)·D-0380-2022·2022-01-26
Rite Aid Allergy & Congestion Tablets Fail Dissolution Specifications
Rite Aid Pharmacy is recalling Allergy & Congestion extended-release tablets because two lots failed to meet dissolution specifications. The affected product was distributed nationwide.
Product
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0388-2022·2022-01-26
Drug Recall: Mucus Relief D Subpotent Tablets
Dr. Reddy's Laboratories is recalling Mucus Relief D (Guaifenesin Pseudoephedrine HCl ER Tablets) nationwide due to subpotency. The affected product was distributed to Walgreen Co. stores across the USA.
Product
Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3
Category
Drug
Distribution
Distributed nationwide