Why it was recalled
Lack of Assurance of Sterility
Product description
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
Lot numbers, UPCs & expiration codes
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0863-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 20, 2026
- FDA report date
- Sep 30, 2026
- Quantity
- 107,377 packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sterling Pharmaceutical Services LLC
Original FDA data
Every field from FDA enforcement report D-0863-2026, exactly as published.
Show all FDA fields
- City
- Dupo
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99712
- Address
- 109 S 2nd St
- Code information
- Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
- Postal code
- 62239-1351
- Report date
- Sep 30, 2026
- Product type
- Drugs
- Recall number
- D-0863-2026
- Classification
- Class II
- Recalling firm
- Sterling Pharmaceutical Services LLC
- Product quantity
- 107,377 packs
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Aug 20, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2026