CLASS III ONGOING Drug recall · Reported 8 Jan 2025 · FDA Enforcement Report
Polyvinyl Alcohol Ophthalmic Solution recalled by AvKARE
AvKARE is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, distributed nationwide in the US. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0176-2025
- FDA event ID
- 96032
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Polyvinyl Alcohol
- Manufacturer
- AvPAK
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 2 Jan 2025
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Eye Drops
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 2 Jan 2025 | Classified by FDA | +15 days |
| 8 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
LABELING: LABEL MIX-UP
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
LABELING: LABEL MIX-UP
Which lots are affected?
Lot #: 0160, Exp. Date April 26 2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96032This product is part of a recall event; the main page for the event is Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARE.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Carboxymethylcellulose Sodium Ophthalmic Solution recalled by AvKARECarboxymethylcellulose Sodium | AvKARE | Packaging Defects | Nationwide |
More recalls from AvKARE
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Polyvinyl Alcohol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Sterile Lubricant Eye Drops recalledLeader Artificial Tears 15 Ml | K.C. Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Polyvinyl Alcohol Ophthalmic Solution recalledPolyvinyl Alcohol | BRS Analytical Services | Sterility | Nationwide |
| Drug | CLASS I | Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Eye Irritation Relief (Polyvinyl alcohol recalledEyes Irritation Relief | Cardinal Health | Sterility | Nationwide |