The Recall Desk

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.

1751–1775 of 3531

  • ModerateFDA (Drugs)·D-0150-2023·2023-01-25

    Antihistamine eye drops recalled due to manufacturing process deviations

    Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0134-2023·2023-01-25

    Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations

    Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.

    Product
    Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
    Category
    Drug
    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-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-0137-2023·2023-01-25

    FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects

    Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.

    Product
    Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
    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-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-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 (Drugs)·D-0149-2023·2023-01-25

    Olopatadine HCl ophthalmic solution recalled for manufacturing deviations

    Olopatadine HCl Ophthalmic Solution 0.2% manufactured by Akorn, Inc. is being recalled nationwide due to Current Good Manufacturing Practice (CGMP) deviations affecting 173,928 bottles.

    Product
    Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12
    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 (Food)·F-0271-2023·2023-01-25

    Klosterman Baking Bagels Recalled Due to Insanitary Storage Conditions

    Klosterman Baking Company is recalling approximately 109,343 Everything bagels distributed in Indiana, Ohio, and Tennessee because products were held under insanitary conditions.

    Product
    Breads: Everything product 9545 Old World Bagels 6 4 oz.
    Category
    Food
    Distribution
    3 states
  • 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-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 (Drugs)·D-0136-2023·2023-01-25

    Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations

    Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.

    Product
    Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-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-0160-2023·2023-01-25

    Triamterene and Hydrochlorothiazide Capsules Recalled for Failed Quality Specifications

    Lannett Company is recalling Triamterene and Hydrochlorothiazide Capsules nationwide because certain lots failed impurity and degradation quality specifications. Consumers taking affected lots should consult their pharmacist or physician.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (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 (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 (Food)·F-0277-2023·2023-01-25

    Klosterman Baking Company Breads Recalled for Insanitary Handling Conditions

    Klosterman Baking Company is recalling breads and buns distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions.

    Product
    Breads: Milk & Egg product 8098 Clear Bag Buns 8 2.5 oz. Milk & Egg product 8099 Clear Bag Buns 8 2.65 oz Milk & Egg product 8608 Clear Bag Buns 6 1.5 oz.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0146-2023·2023-01-25

    Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues

    Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.

    Product
    Ofloxacin 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: 13985-602-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0232-2023·2023-01-18

    Dole Chopped Kit Salad Recalled for Potential Chemical Residue from Washing Error

    Dole Fresh Vegetables is recalling certain Chopped Kit salads because an incorrect foam detergent was used in the vegetable wash system. The recall affects approximately 6,451 cases distributed to 12 U.S. states.

    Product
    Dole Chopped Kit Avocado Ranch Green Leaf Lettuce, Green Cabbage, Red Cabbage, Kale, Carrots, Green Onions, Cheddar Cheese, Creamy Avocado Ranch Dressing, Crispy Corn Thoroughly Washed Perishable/Keep Refrigerated Salad & Toppings NET WT: 8.8 OZ (248 g) Dressing NET: 2.5 FL OZ (7
    Category
    Food
    Distribution
    12 states