HIGHFDA DRUG

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur...

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
June 4, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 4, 2026
Hazard Level
HIGH
Brands
PREDNISOLONE ACETATE, Lupin Pharmaceuticals, Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PREDNISOLONE ACETATE, Lupin Pharmaceuticals, Inc.
Model numbers
Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026, HA00987 +12 more
UPC codes
70748-332, 70748-332-03, 70748-332-02, 70748-332-04
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 4, 2026

  2. Reported by FDA DRUG

    July 8, 2026

  3. RecallRadar source check

    July 14, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Presence of Foreign Substance

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Lupin Pharmaceuticals Inc. or your healthcare provider for guidance. Notification method: Letter

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Full Description

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA. Generic: PREDNISOLONE ACETATE; Brand: PREDNISOLONE ACETATE. Reason: Presence of Foreign Substance. Classification: Class II. Quantity: 2,530,182 bottles. Distribution: U.S. Nationwide

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lots: a) HA00937
HA00939
HA00941
HA00971
H00973
+15 more
UPC Codes
70748-332
70748-332-03
70748-332-02
+1 more
Affected States
ALL
Report Date
July 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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