FDA drug recalls · openFDA

Is CARBOXYMETHYLCELLULOSE SODIUM recalled?

The FDA has recorded 7 recalls of CARBOXYMETHYLCELLULOSE SODIUM (2023–2025) , recalled under brands like CARBOXYMETHYLCELLULOSE SODIUM, DRY EYE RELIEF, LUBRICANT DROPS. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of CARBOXYMETHYLCELLULOSE SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the ma 3

Non-Sterility 2

LABELING: LABEL MIX-UP 1

cGMP deviations and lack of assurance of sterility. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, St Class I ongoing

Cardinal Health Inc. 2023-10-31 lots: ALL LOTS

LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed Class I ongoing

Cardinal Health Inc. 2023-10-31 lots: ALL LOTS

Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single P Class I ongoing

Kilitch Healthcare India Limited 2023-11-13 lots: All lots

Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health D Class I ongoing

Kilitch Healthcare India Limited 2023-11-13 lots: All lots

LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dist Class I ongoing

Cardinal Health Inc. 2023-10-31 lots: ALL LOTS

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Ey Class II ongoing

BRS Analytical Services, LLC 2025-04-23 lots: Lot, expiry: Lot 103, exp 4/26/25; Lot 104, exp 5/03/25; Lot 108, exp 6/29/25; Lot 109, exp 7/18/25; Lot 110, exp 8/17/25; Lot 111, exp 8/22/25; Lot 112, exp 8/27/25; Lot 113, exp 9/18/25; Lot 125, exp 10/23/25; Lot 130, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/25; Lot 136, exp 12/14/25; Lot 137, exp 1/02/26; Lot 139, exp 1/15/26; Lot 140, exp 1/19/26; Lot 141, exp 1/25/26; Lot 151, exp 3/18/26; Lot 152, exp 3/21/26; Lot 153, exp 3/25/26; Lot 154, exp 3/28/26; Lot 155, exp 4/01/26; Lot 156, exp 4/08/26; Lot 157, exp 4/11/26; Lot 160, exp 4/26/26; Lot 180, exp 8/08/26; Lot 181, exp 8/12/26; Lot 182, exp 8/18/26; Lot 183, exp 8/21/26; Lot 184, exp 8/26/26; Lot 185, exp 9/04/26; Lot 186, exp 9/09/26; Lot 187, exp 9/16/26; Lot 188, exp 9/18/26; Lot 189, exp 9/21/26; Lot 190, exp 9/25/26; Lot 191, exp 9/28/26; Lot 192, exp 10/02/26; Lot 208, exp 12/11/26; Lot 209, exp 12/16/26; Lot 212, exp 1/15/27; Lot 213, exp 1/21/27; Lot 214, exp 1/24/27; Lot 215, exp 2/02/27; Lot 216, exp 2/04/27; Lot 224, exp 3/27/27.

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Dist Class III ongoing

AvKARE 2024-12-18 lots: Lot #: 0160, Exp. Date April 26 2026

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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