Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

3051–3075 of 3531

ModerateFDA (Food)·F-0343-2022·2021-12-29
Cesarina Cookies Recalled Due to Undeclared Milk
Cesarina Bakery, Inc. is recalling Cesarina Cookies, Fiochetto, Apricot Raspberry Guava (16oz boxes) because they contain undeclared milk, a common allergen. The recall affects domestic distribution and applies to multiple lot codes with expiration dates ranging from March 2022 through May 2022.
Product
Cesarina Cookies, Fiochetto, Apricot Raspberry Guava, Net Weight 16oz (453.59g)
Category
Food
Distribution
0 states
ModerateCPSC·22042·2021-12-29
American Angler Electric Fillet Knives Recalled for Laceration Hazard
Scott Fetzer Consumer Brands is recalling about 43,200 American Angler Electric Fillet Knives because the trigger mechanism can become stuck in the "on" position, posing a laceration hazard to users.
Product
American Angler Electric Fillet Knives
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0344-2022·2021-12-29
Cesarina Cookies Tutti Frutti Recalled for Undeclared Milk
Cesarina Bakery, Inc. is recalling Cesarina Cookies Tutti Frutti (16 oz) because the product contains undeclared milk, a common allergen not listed on the label.
Product
Cesarina Cookies, Tutti Frutti Cookies, Net Weight 16oz (453.59g)
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0327-2022·2021-12-22
Kool-Aid Cherry Drink Mix Powder Recalled for Glass and Metal Contamination
Kraft Heinz Foods Company is recalling Kool-Aid cherry drink mix powder in multiple sizes due to potential glass and metal contamination. The recall affects 289,221 cases distributed nationwide and internationally.
Product
Kool-Aid cherry drink mix powder 19 oz. UPC 043000953532 19 oz. UPC 043000034163 63 oz. UPC 043000082201
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0391-2022·2021-12-22
Astra XT DR Patient Identification Cards Printed with Incorrect MR Statement
Medtronic is recalling Astra XT DR patient identification cards that were printed with an incorrect statement about MR safety conditional status. The erroneous cards were distributed in the US, Canada, and Northern Mariana Islands.
Product
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0285-2022·2021-12-22
Telmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency
Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg due to superpotency. The affected batch (BZ74G001, expiring 12/2021) contains approximately 27,312 bottles distributed nationwide.
Product
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0279-2022·2021-12-22
Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0332-2022·2021-12-22
Tang Orange Drink Mix Powder Recall for Potential Glass and Metal Contamination
Kraft Heinz Foods Company is recalling Tang orange drink mix powder in three sizes due to potential contamination with glass and metal particles. The affected product was distributed nationwide and internationally.
Product
Tang orange drink mix powder 20 oz. UPC 043000032275 58.9 oz. UPC 043000082171 72 oz. UPC 043000032268
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0319-2022·2021-12-22
Mother's Milk Bank of North Texas Pasteurized Donor Human Milk Recalled for Foreign Object
Mother's Milk Bank of North Texas is recalling 54 bottles of pasteurized donor human milk (100 mL each, batch 025958-1) distributed in Texas because a foreign object was found in a bottle.
Product
Mother's Milk Bank of North Texas 817-810-0071 Pasteurized Donor Human milk Volume: 100mL 1.00 g/dL Protein packaged in sterile BPA free plastic bottle
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0384-2022·2021-12-22
BioGlue Surgical Adhesive recalled for unauthorized distribution in European Union
CryoLife's BioGlue Surgical Adhesive (Model BG3510-5-G) was distributed in the European Union without required regulatory approval. The product should not have been distributed in that region.
Product
BioGlue Surgical Adhesive, Model BG3510-5-G
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0388-2022·2021-12-22
Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.
Product
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Medical Device
Distribution
15 states
ModerateFDA (Drugs)·D-0282-2022·2021-12-22
Clindamycin and Benzoyl Peroxide Gel Recalled for Superpotent Formulation
TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, nationwide due to a superpotent (higher-than-intended active ingredient) formulation. The voluntary recall affects three specific lots.
Product
Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0390-2022·2021-12-22
Medical Device ID Cards incorrectly printed with MR conditional system statement
Medtronic is recalling 187 Medical Device Identification Cards for Sprint Quattro Lead implants printed with an erroneous statement about MR conditional system status. Affected cards were distributed in the US, Canada, and Northern Mariana Islands.
Product
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0362-2022·2021-12-22
Bedside PICC CDS Convenience Kit Recalled for Expired Saline Component
Medline Industries is recalling the Bedside PICC CDS Convenience Kit because a saline injection bag component expired in April 2020 while the kit's expiration date was later. No injuries have been reported.
Product
Bedside PICC CDS Convenience Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0283-2022·2021-12-22
Methylcobalamin Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.
Product
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0284-2022·2021-12-22
B-Complex Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.
Product
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0329-2022·2021-12-22
Kool-Aid Strawberry Drink Mix Recalled for Glass and Metal Contamination
Kraft Heinz Foods Company is recalling Kool-Aid strawberry drink mix powder (19 oz.) due to potential glass and metal contamination. The recall affects approximately 289,221 cases distributed nationally and internationally.
Product
Kool-Aid strawberry drink mix powder 19 oz. UPC 043000953556
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0382-2022·2021-12-22
Bartels Legionella Urinary Antigen test recalled due to reagent contamination
Clark Laboratories is recalling the Bartels Legionella Urinary Antigen diagnostic test due to contamination in the test reagent that may cause invalid results. The affected test kits were distributed in Ohio and Utah.
Product
Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen in human urine. Product Code: B1029-440
Category
Medical Device
Distribution
2 states
ModerateFDA (Drugs)·D-0281-2022·2021-12-22
Lidocaine Hydrochloride Topical Solution recalled for CGMP deviations
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. Affected lots were made at a facility where cracked seals in caps were found on related products.
Product
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0278-2022·2021-12-22
Diclofenac Sodium Topical Solution Recalled for Leaking Bottles
Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Category
Drug
Distribution
3 states
ModerateFDA (Food)·F-0271-2022·2021-12-15
Gerber Macaroni and Cheese Recalled for Beetles in Peas
Gerber is recalling Macaroni and Cheese with peas and carrots due to beetles found in the pea ingredient in the side compartment. The affected product has a best-by date of 04 Oct 2022.
Product
GERBER Macaroni and Cheese with a side of peas and carrots, 6.6 oz. (187 g) drained weight 5.3 oz. (150 g), 8 units per case.
Category
Food
Distribution
12 states
ModerateFDA (Drugs)·D-0269-2022·2021-12-15
OTC Allergy and Congestion Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0334-2022·2021-12-15
Orthodontic Software Documentation Recalled for Unapproved Labeling Changes
Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.
Product
O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0267-2022·2021-12-15
Allergy and Congestion tablets recalled due to failed dissolution specifications
Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.
Product
ALLERGY AND CONGESTION — ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateCPSC·22033·2021-12-15
Ceiling Fans Recalled Due to Detaching Blades Impact Injury Risk
About 77,900 Harbor Breeze Belleisle Bay and Honeywell Rio ceiling fans are recalled because the blades can detach during use and strike consumers or cause property damage.
Product
Harbor Breeze Belleisle Bay and Honeywell Rio Ceiling Fans
Category
Consumer Product
Distribution
Distributed nationwide