Eye Drops Recall Covers 2.5M Bottles Nationwide

More than 2.5 million bottles of prescription prednisolone acetate eye drops are under a nationwide recall after regulators classified the action as a Class II recall.

The recalled product is Prednisolone Acetate Ophthalmic Suspension, USP, 1%, manufactured by Lupin Limited and distributed in 5-mL, 10-mL and 15-mL bottles.

The recall was tied to the presence of a foreign substance. For patients, the important step is not only knowing that eye drops were recalled, but checking the bottle size, National Drug Code, lot number and expiration date against the recall list.

The recall covers prescription steroid eye drops

Prednisolone acetate ophthalmic suspension is a steroid eye drop used for inflammatory eye conditions.

Lupin’s product was approved as a generic version of Pred Forte, with the company describing it as a treatment for steroid-responsive inflammation involving parts of the eye including the conjunctiva, cornea and anterior segment.

The recall does not cover every eye drop product on the market.

It applies to specific lots of Lupin’s prednisolone acetate ophthalmic suspension, USP, 1%, across three bottle sizes.

Patients should check the product label carefully before assuming their medication is affected.

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Which eye drop bottles are affected

The affected product is:

Product: Prednisolone Acetate Ophthalmic Suspension, USP, 1%

Manufacturer: Lupin Limited

Bottle sizes: 5 mL, 10 mL and 15 mL

Recall classification: Class II

Reason: Presence of a foreign substance

Patients should check three details on the bottle or carton:

• Bottle size

• National Drug Code

• Lot number

The expiration date should also match the affected lot group.

5-mL bottles

NDC: 70748-332-02

Affected lots include:

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, HA01133 — expires 9/30/2026

HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220 — expires 10/31/2026

HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298 — expires 11/30/2026

HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043 — expires 12/31/2026

HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084 — expires 1/31/2027

HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200 — expires 2/28/2027

HB00224, HB00226, HB00228, HB00230, HB00240, HB00242 — expires 3/31/2027

HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, HB00465 — expires 5/31/2027

HB00561 — expires 6/30/2027

HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, HB00679 — expires 10/31/2027

HB00747, HB00749, HB00751, HB00753 — expires 11/30/2027

HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, HC00028 — expires 12/31/2027

HC00030, HC00032 — expires 1/31/2028

HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, HC00083 — expires 2/29/2028

HC00091 — expires 3/31/2028

10-mL bottles

NDC: 70748-332-03

Affected lots include:

HA00945, HA00947, HA00949 — expires 7/31/2026

HA01160, HA01162, HA01164 — expires 10/31/2026

HA01234, HA01300, HA01302 — expires 11/30/2026

HB00053, HB00055, HB00057 — expires 1/31/2027

HB00107, HB00109, HB00111, HB00151, HB00153, HB00155 — expires 2/28/2027

HB00386, HB00388, HB00390, HB00445, HB00447 — expires 5/31/2027

HB00549, HB00551, HB00553, HB00555 — expires 6/30/2027

HB00700, HB00702 — expires 10/31/2027

HB00771 — expires 11/30/2027

HC00008, HC00010 — expires 12/31/2027

HC00034, HC00038, HC00054, HC00060 — expires 1/31/2028

15-mL bottles

NDC: 70748-332-04

Affected lots include:

HA00951, HA00953, HA00955 — expires 7/31/2026

HA01188, HA01190, HA01192 — expires 10/31/2026

HA01304 — expires 11/30/2026

HB00113, HB00115 — expires 1/31/2027

HB00166, HB00168 — expires 2/28/2027

HB00392, HB00394, HB00396 — expires 5/31/2027

HB00545, HB00547 — expires 6/30/2027

HB00704 — expires 10/31/2027

HB00773 — expires 11/30/2027

HC00012, HC00014 — expires 12/31/2027

HC00066, HC00068 — expires 2/29/2028

Why Class II matters

A Class II recall is not the highest recall category, but it still means the product should be taken seriously.

FDA recall definitions describe Class II recalls as situations where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the chance of serious harm is remote.

For this recall, the risk is tied to foreign particulate matter in a prescription eye product.

That is different from a packaging typo or a minor labeling issue.

The affected medication is used directly in the eye, where irritation, inflammation or injury can have immediate consequences for comfort and vision.

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The risk is local eye injury, not a broad infection claim

Distributor recall material linked the foreign particulate complaint to possible local inflammatory response, mechanical irritation, corneal injury, inflammation and a potential risk of secondary ocular infection.

That does not mean every affected bottle has caused harm.

It means the product failed a safety threshold serious enough for a retail-level recall.

Patients should not try to inspect the liquid and decide it is safe by sight alone.

Particles may not be easy to see, and the recall is based on lot identification rather than a patient’s visual inspection of the bottle.

Do not stop prescribed steroid drops without advice

Prednisolone acetate eye drops are often prescribed after eye procedures or for inflammatory eye conditions.

Stopping a steroid eye drop suddenly may create problems if the medicine is controlling inflammation.

Patients with an affected lot should contact the prescribing ophthalmologist, optometrist, pharmacist or clinic before stopping or replacing the medication.

That advice is especially important for patients using the drops after surgery or for active eye inflammation.

A pharmacist can help confirm the NDC and lot number, while the prescribing clinician can decide whether the patient needs a replacement medication or a different treatment plan.

What patients should do now

Patients should check the label on the bottle and carton against the affected lot list.

Anyone with a matching NDC and lot number should set the bottle aside, avoid using it unless a clinician gives specific direction, and contact the pharmacy or prescriber for next steps.

Patients should keep the bottle and packaging until they receive return or disposal instructions.

They should also save prescription records, pharmacy receipts and any messages from the pharmacy or clinic.

Anyone who has used an affected bottle and develops eye pain, increased redness, vision changes, discharge, severe irritation or worsening inflammation should seek medical advice promptly.

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Pharmacies and clinics have a separate burden

Retail-level recalls put pressure on pharmacies, clinics and distributors to identify affected inventory and contact patients when recalled stock may have been dispensed.

The product list is long because the recall covers many lots across multiple bottle sizes.

That makes label checking more important than relying on the product name alone.

A patient may have prednisolone acetate eye drops that are not part of this recall.

Another patient may have the same drug name, same strength and same manufacturer but a lot number that is included.

The lot number is the deciding detail.

Eye drop recalls have become a higher-sensitivity issue

Eye drop safety has received more public attention after previous recalls involving sterility concerns, contamination risks and manufacturing problems.

This recall involves a prescription steroid suspension, not an over-the-counter artificial tear product.

That distinction matters for patient behavior.

People using prescription steroid drops should not simply switch to a different over-the-counter product without medical guidance.

The safer path is direct confirmation with the pharmacy or prescribing eye-care professional.

The useful check is simple

The product name alone is not enough.

Patients should check the full label:

Prednisolone Acetate Ophthalmic Suspension, USP, 1%.

Then check bottle size.

Then check NDC.

Then check the lot number and expiration date.

If all details match the recall list, the patient should contact a pharmacist or eye-care professional for replacement and safety guidance.

Sources

• FDA enforcement report for Lupin prednisolone acetate ophthalmic suspension recall

• FDA recall background and definitions

• Lupin prednisolone acetate ophthalmic suspension approval information

• Hilco Vision recall notice for prednisolone acetate ophthalmic suspension

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