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.

4551–4575 of 21589

ModerateFDA (Drugs)·D-0878-2022·2022-05-25
Phenobarbital Elixir recalled for exceeding alcohol content specification
Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.
Product
Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0872-2022·2022-05-25
Accupril tablets recalled by Pfizer for nitrosamine impurity
Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.
Product
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1063-2022·2022-05-25
Chocolate Caramels Recalled for Undeclared Soy Lecithin
R & S Roberts Enterprises recalls Milk & Dark Chocolate Sea Salt Caramels due to undeclared soy lecithin used in the releasing agent. The product may cause reactions in consumers with soy allergies.
Product
Milk & Dark Chocolate Sea Salt Caramels. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11713 2.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1078-2022·2022-05-25
Getinge Washer Disinfector models recalled for inadequate installation documentation
Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.
Product
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Category
Medical Device
Distribution
34 states
ModerateFDA (Devices)·Z-1109-2022·2022-05-25
VERIGENE extraction tray reagent defect causes test control failures
Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.
Product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0871-2022·2022-05-25
Antacid Suspension Recalled for Failed Microbial Testing
Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.
Product
Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0881-2022·2022-05-25
Sirolimus Oral Solution Recalled for Failed Dissolution Specifications
Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.
Product
SIROLIMUS — SIROLIMUS (SIROLIMUS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1103-2022·2022-05-25
HeartWare HVAD System Controller Recalled for Translation Errors in Documentation
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1110-2022·2022-05-25
Documentation errors recalled in HeartWare HVAD instructions and manuals
Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.
Product
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1090-2022·2022-05-25
Total Resources International First Aid Kits Recalled Due to Cross-Contamination Risk
Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.
Product
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.
Category
Medical Device
Distribution
30 states
ModerateCPSC·22135·2022-05-19
Hover-1 Superfly Hoverboards Recalled Due to Fall and Injury Hazards
DGL Group is recalling approximately 93,000 Hover-1 Superfly Hoverboards sold between October 2020 and October 2021 at Best Buy due to a software malfunction that causes uncontrolled momentum when the rider is not actively controlling the board.
Product
Hover-1 Superfly Hoverboards
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22748·2022-05-19
Moderne Glass Company Recalls 15-Ounce Coffee Cups for Burn Hazard
Moderne Glass Company is recalling about 2,500 ceramic coffee cups that can crack or break when hot water is poured into them, posing a burn hazard. No injuries have been reported. Consumers should stop using the cups immediately and contact the company for a refund.
Product
Coffee cups
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1060-2022·2022-05-18
First Aid Kits and Cabinets Recalled for Manufacturing Deviations
Certified Safety Mfg Inc is recalling first aid kits and cabinets containing Medi-First medication components due to manufacturing practice deviations at the component supplier.
Product
The following first aid kits and cabinets containing components Medi-First XS Non-Aspirin, Product #80450, 2 tablets/packet, 25 packets/box; and Sinus Pain & Pressure, Product #81950, 2 tablets/packet, 25 packets/box. Product number and description: (1) K614-020 16PW - Fir
Category
Medical Device
Distribution
36 states
ModerateFDA (Drugs)·D-0866-2022·2022-05-18
FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient
Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.
Product
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1053-2022·2022-05-18
Bwell Bird's Nest Beverage Recalled Due to Deficient Packaging Material
Eastland Food Corporation is recalling Bwell Bird's Nest Beverage Honey Flavor because deficient packaging may cause premature spoilage. The product was distributed to retail stores in 34 states.
Product
Bwell Bird's Nest Beverage Honey Flavor NET 8.45 FL OZ (250mL) UPC 8373726346 24 bottles per case
Category
Food
Distribution
34 states
ModerateFDA (Food)·F-1051-2022·2022-05-18
Bwell Bird's Nest Beverage Recalled for Deficient Packaging
Bwell Bird's Nest Beverage Pandan Flavor is being recalled due to deficient packaging material that may lead to premature spoilage. The recall affects 1,699 cases distributed to retail stores across 33 states.
Product
Bwell Bird's Nest Beverage Pandan Flavor NET 8.45 FL OZ (250mL) UPC 8373726342 24 bottles per case
Category
Food
Distribution
34 states
ModerateFDA (Drugs)·D-0863-2022·2022-05-18
FDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide
Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed nationwide.
Product
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1051-2022·2022-05-18
CABG Surgical Kit Recall Due to Improper Shipping Box Packing
ROi CPS LLC is recalling 85 Regard brand CABG Packs due to incorrect packing into shipping boxes. One North Carolina healthcare facility received the affected kits.
Product
Regard brand CABG Pack A and B - Spartanburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Drugs)·D-0864-2022·2022-05-18
FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron
Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.
Product
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1054-2022·2022-05-18
Bwell Bird's Nest Beverage Recalled Due to Deficient Packaging
Bwell Bird's Nest Beverage is being recalled due to deficient packaging material that could lead to premature spoilage. The recall affects 1,699 cases distributed across 34 states.
Product
Bwell Bird's Nest Beverage Rock Sugar Flavor NET 4.45 FL OZ (250mL) UPC 8373726348 24 bottles per case
Category
Food
Distribution
34 states
ModerateFDA (Food)·F-1052-2022·2022-05-18
Bwell Bird's Nest Beverage Coconut Flavor Recalled for Deficient Packaging
Eastland Food Corporation is recalling Bwell Bird's Nest Beverage Coconut Flavor due to deficient packaging material that could lead to premature spoilage. Approximately 1,699 cases were distributed to retail stores across multiple states.
Product
Bwell Bird's Nest Beverage Coconut Flavor NET 8.45 FL OZ (250mL) UPC 8373726344 24 bottles per case
Category
Food
Distribution
34 states
ModerateFDA (Drugs)·D-0857-2022·2022-05-18
Bupropion Hydrochloride 150 mg Extended-Release Tablets Recalled for Activated Carbon Contamination
Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0865-2022·2022-05-18
Prescription Compounding Drug Nandrolone Decanoate Recalled for Subpotency
Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate USP used for prescription compounding because the product is subpotent, containing less active ingredient than expected. The recall is nationwide.
Product
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1040-2022·2022-05-18
ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.
Product
ACS Cath Lab Pack
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1056-2022·2022-05-18
Bwell Bird's Nest Sugar-Free Xylitol Beverage Recalled for Deficient Packaging Material
Bwell Bird's Nest Beverage Sugar-Free Xylitol is recalled due to deficient packaging material that may lead to premature spoilage. The FDA Class II recall affects 1,699 cases distributed across 34 U.S. states.
Product
Bwell Bird's Nest Beverage Sugar-Free Xylitol NET 8.45 FL OZ (250mL) UPC 8373726352 24 bottles per case
Category
Food
Distribution
34 states