State

Colorado product recalls

20,364 recalls have nationwide distribution and so reach Colorado. 0 additional recalls listed Colorado specifically in their distribution scope.

About recalls in Colorado

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Colorado consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

14526–14550 of 20364

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
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 (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 (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-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-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-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-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-0155-2023·2023-01-25
Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations
Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0151-2023·2023-01-25
Prescription eye drop recall due to manufacturing compliance issues
Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
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 (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 (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-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-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-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-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 (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-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-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-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-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-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