The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1368-2020·Announced 2020-07-01

Rising Pharmaceuticals Recalls Timolol Maleate Ophthalmic Solution Due to Labeling Error

Rising Pharmaceuticals is recalling 15,072 bottles of Timolol Maleate 0.25% ophthalmic solution because some outer cartons were mislabeled as 0.5% strength.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a minor labeling error where the outer carton strength did not match the bottle, but the bottle itself was correctly labeled and contained the correct medication.

Plain-English summary

Rising Pharmaceuticals, Inc. is recalling 15,072 bottles of Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5 mL, NDC 64980-513-05. The recall was initiated due to a labeling mix-up where the outer carton for the 0.25% strength product was mistakenly labeled as the 0.5% strength product, while the bottle inside contained the correct 0.25% solution.

The affected product is distributed nationwide in the U.S.A. The specific lot number is 089A016, with an expiration date of 12/2020. The product is a prescription-only ophthalmic solution manufactured by FDC Limited in India and distributed by Rising Pharmaceuticals, Inc. in Saddle Brook, NJ.

Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If the outer carton indicates 0.5% strength but the bottle indicates 0.25%, the product should be returned to the distributor or disposed of according to local regulations. No adverse health consequences are expected from this labeling error, as the actual medication strength in the bottle matches the bottle label.

The recalled product

Product
TIMOLOL MALEATE (TIMOLOL MALEATE)
Brand
TIMOLOL MALEATE
Manufacturer
Rising Pharmaceuticals, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
15,072

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 (2)

  • Lot # 089A016
  • Exp 12/2020

UPCs (2)

  • 0364980513050
  • 0364980514057

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Rising Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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