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.

3776–3800 of 21589

ModerateFDA (Devices)·Z-1019-2023·2023-02-01
Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device
SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.
Product
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·23V032000·2023-01-27
2023 Winnebago Revel: incorrect tire size on safety label
Certain 2023 Winnebago Revel camper vans have an incorrect tire size listed on the Tire and Loading Information Label (R16 instead of R17). Installing the wrong tires based on this incorrect information could increase the risk of a crash.
Product
WINNEBAGO — WINNEBAGO REVEL
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0274-2023·2023-01-25
Garlic Bread Products Recalled for Insanitary Holding Conditions
Klosterman Baking Company is recalling garlic bread rolls and breadsticks held under insanitary conditions. Approximately 109,343 units were distributed in Indiana, Ohio, and Tennessee from December 12-16.
Product
Breads: Garlic product 8013 Clear Bag Rolls 140 1.5 oz. 3 Garlic product 8014 Clear Bag Breadsticks 110 1.5 oz. 23
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0167-2023·2023-01-25
SINUVA Sinus Implant Recalled for Failed Drug Release Specification
Intersect ENT, Inc. is recalling 9,898 pouches of SINUVA sinus implants nationwide after detecting failed drug release specifications during stability testing. The implant may not deliver the medication as intended.
Product
SINUVA — SINUVA (MOMETASONE FUROATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0148-2023·2023-01-25
Ophthalmic solution recalled due to manufacturing quality control deviations
Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.
Product
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0283-2023·2023-01-25
Klosterman Rye Bread Recalled Due to Insanitary Holding Conditions
Klosterman Baking Company is recalling rye bread products held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee between December 12–16.
Product
Breads: Rye product 1495 Klosterman Retail UPC # 0005172100109 Loaf 1 16 oz. Rye product 1505 Clear Bag Loaf 1 32 oz. Rye product 1525 Klosterman Foodservice UPC # 0005172100456 Loaf 1 24 oz. Rye product 1545 Klosterman Retail UPC # 0005172100108 Loaf 1 16 oz. Rye product 1550
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-0287-2023·2023-01-25
White Breads and Buns Recalled for Insanitary Storage Conditions
Klosterman Baking Company is recalling certain white bread and bun products due to storage under insanitary conditions. The recall affects products distributed in Indiana, Ohio, and Tennessee between December 12-16, 2022.
Product
Breads: White product 1003 Clear Bag Loaf 1 24 oz. White product 1005 Clear Bag Loaf 1 24 oz. White product 1015 Clear Bag Loaf 1 24 oz. White product 1020 Clear Bag Loaf 1 24 oz. White product 1040 Klosterman Foodservice UPC # 0005172100450 Loaf 1 32 oz. White product 10
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0138-2023·2023-01-25
Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations
Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.
Product
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0158-2023·2023-01-25
FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues
Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.
Product
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0269-2023·2023-01-25
Klosterman Cuban Bread Recalled Due to Insanitary Storage Conditions
Klosterman Baking Company recalls 109,343 loaves of Cuban bread held under insanitary storage conditions. The affected products were distributed in Indiana, Ohio, and Tennessee between December 12 and 16.
Product
Breads: Cuban product 8506 Clear Bag Loaf 1 16 oz.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0163-2023·2023-01-25
Hand Sanitizer Recalled for Manufacturing Practice Deviations
Fisher Scientific voluntarily recalls HSANI500ML hand sanitizer (75% isopropyl alcohol) due to manufacturing practice deviations. The product was made under expired temporary FDA approval.
Product
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0152-2023·2023-01-25
FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.
Product
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0267-2023·2023-01-25
Klosterman Baking Company cornmeal buns recalled due to insanitary storage conditions
Klosterman Baking Company is recalling cornmeal buns due to insanitary storage conditions. About 109,343 units distributed in IN, OH, and TN between December 12-16 are affected. No illnesses have been reported.
Product
Breads: Cornmeal product 3630 Clear Bag Buns 12 100 g
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-0265-2023·2023-01-25
Blueberry Bagels Recalled Due to Insanitary Storage Conditions
Klosterman Baking Company recalls Old World brand blueberry bagels due to products being held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee.
Product
Breads: Blueberry product 9531 Old World Bagels 6 3 oz. Blueberry product 9541 Old World Bagels 6 4 oz.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0164-2023·2023-01-25
Hand Sanitizer Recalled Due to Manufacturing Practice Deviations
Fisher Scientific voluntarily recalls hand sanitizer due to manufacturing deviations. The recall affects products distributed after March 31, 2022.
Product
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0143-2023·2023-01-25
Lidocaine Hydrochloride Jelly Recalled for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.
Product
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0999-2023·2023-01-25
R&D CBC-3D Hematology Control Recalled for Potential Microbial Contamination
R&D Systems is recalling one lot of CBC-3D Hematology Control due to potential microbial contamination that may cause hemolysis or deterioration in the Normal control level.
Product
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0140-2023·2023-01-25
FDA recalls GONAK ophthalmic drug solution for manufacturing deviations
Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.
Product
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0144-2023·2023-01-25
Akorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations
Akorn, Inc. is recalling 2,563 bottles of Moxifloxacin Ophthalmic Solution nationwide due to manufacturing deviations. The recall is voluntary and affects lot 1E28A with expiration date 4/30/2023.
Product
Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0142-2023·2023-01-25
Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues
Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.
Product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0161-2023·2023-01-25
Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications
Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because the medication failed quality testing for impurity and degradation specifications. The recall affects 20,040 bottles.
Product
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0162-2023·2023-01-25
Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch
Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.
Product
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0266-2023·2023-01-25
Klosterman ciabatta bread rolls recalled for insanitary holding conditions
Klosterman Baking Company is recalling ciabatta bread rolls distributed to Indiana, Ohio, and Tennessee because they were held under insanitary conditions. Consumers should dispose of affected products.
Product
Breads: Ciabatta product 8000 Clear Bag Rolls 8 3.4 oz. Ciabatta product 8652 Clear Bag Rolls 6 5.5 oz.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0145-2023·2023-01-25
FDA recalls Akorn ophthalmic ointment for manufacturing process deviations
Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.
Product
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0154-2023·2023-01-25
Drug recall: Proparacaine eye solution due to manufacturing deviations
Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 23,026 bottles distributed nationwide.
Product
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15
Category
Drug
Distribution
Distributed nationwide