Artificial Tears Eye Drops Recalled Due to Manufacturing Facility Contamination
Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall. Confirmed contamination in eye drops poses a risk of eye infection and injury, even though no illnesses have been reported to date. The manufacturing facility deviations that led to contamination support a High severity rating.
Plain-English summary
Delsam Pharma Llc is recalling all lots of its ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops (10 mg in 1 ml, 1%, 1/2 fl oz/15 ml bottles) due to confirmed contamination. The recall was issued by the FDA as a Class II action after contamination was detected in certain lots manufactured at the same facility under identical conditions.
The recalled product was manufactured by Global Pharma Healthcare Private Limited and distributed nationwide in the USA through two distributors. The affected lot numbers are PCMH003, PCMH004, PCMH006, and PCMH008, all with expiration dates in November 2023. A total of 400,008 bottles have been recalled.
Consumers should discontinue use of the affected product immediately. Anyone who has used these eye drops should consult their healthcare provider if they experience any eye discomfort, irritation, or signs of infection.
The recalled product
- Product
- Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
- Manufacturer
- Global Pharma Healthcare Private Limited
- Category
- Drug — Ophthalmic / Lubricant
- Hazard
- contamination
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: PCMH003
- PCMH004
- PCMH006
- PCMH008
- Exp. date NOV-2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27