Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a foreign substance in an ophthalmic suspension—a risk-of-harm product where potential for serious injury (eye infection, vision impairment) exists. No illnesses or injuries are reported in the source, but the hazard is not purely theoretical given the nature of foreign contaminants in sterile eye medications.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% (a sterile eye drop medication available in 5 mL, 10 mL, and 15 mL bottles) due to the presence of a foreign substance. The product was manufactured by Lupin Limited in Pithampur, India and distributed nationwide in the United States.
Multiple lot numbers of the affected product have been identified, with expiration dates ranging from July 2026 through March 2028. A total of 2,530,182 bottles are involved in this recall. The specific identity of the foreign substance is not detailed in available information.
Patients who have this medication should contact their healthcare provider or pharmacist. Consumers should not use the recalled product and should return it to their pharmacy for proper disposal. Those with questions may contact Lupin Pharmaceuticals.
The recalled product
- Product
- PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
- Brand
- PREDNISOLONE ACETATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 2,530,182
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 (20)
- Lots: a) HA00937
- HA00939
- HA00941
- HA00971
- H00973
- HA00975
- Expires: 7/31/2026
- HA00987
- HA00989
- HA00991
- HA01010
- HA01012
- HA01014
- HA01016
- HA01048
- Expires: 8/31/2026
- HA01120
- HA01137
- HA01129
- HA01138
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PREDNISOLONE ACETATE
- HighPrednisolone Acetate ophthalmic suspension recalled for temperature-abuse during distribution
FDA (Drugs) · 2022-06-15
Same manufacturer · Lupin Pharmaceuticals Inc.
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- ModerateSertraline tablets recalled because bottle seals are not adhering
FDA (Drugs) · 2025-12-17
- ModerateGanirelix acetate injection recalled after failing an impurity specification
FDA (Drugs) · 2025-12-17
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateLupin Recalls Pravastatin Sodium Tablets Due to Foreign Capsule Presence
FDA (Drugs) · 2017-11-29
- HighPrednisolone Acetate ophthalmic suspension recalled for temperature-abuse during distribution
FDA (Drugs) · 2022-06-15
- LowLupin Recalls Cephalexin Oral Suspension Due to Foreign Substance
FDA (Drugs) · 2019-11-13
- SevereLeiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- HighAntibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination
FDA (Drugs) · 2024-05-22
- HighLupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-08-05