Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
LABELING: LABEL MIX-UP
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
Affected NDC
50268-0068-15
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| carboxymethylcellulose sodium NDC 50268-0068 |
, UNSPECIFIED FORM 5 mg/mL | Solution/ Drops Ophthalmic |
AvPAK | OTC |
- Recalling firm
- AvKARE
- NDC code
- 50268-068-15
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0175-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other recalls by AvKARE
All 2024 recalls
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Rosuvastatin Tablets
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Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
Other labeling / mix-up recalls from 2024
All labeling / mix-up recalls
Class I · High risk
Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class III · Low risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
LABELING: LABEL MIX-UP
Class III · Low risk
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
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