Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0278-2022·Announced 2021-12-22

Diclofenac Sodium Topical Solution Recalled for Leaking Bottles

Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% in 150 mL bottles due to container defects that cause leaking. The affected lot was distributed to physician offices in Connecticut, Florida, and Kansas.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a drug product. The hazard is a container integrity defect leading to leakage, which is a precautionary quality issue. No illnesses, injuries, or hospitalizations are reported in the source text, and the distribution was limited to physician consignees rather than widespread retail or patient distribution, making this a moderate-severity precautionary recall.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles (NDC 68788-7707-01, Lot E1220B) due to defective containers that fail integrity specifications, resulting in bottles leaking.

The affected product was distributed to five physician consignees located in Connecticut, Florida, and Kansas. A total of 72 bottles were distributed under this recall.

Patients or healthcare providers who have received this product should stop use immediately. If the medication has leaked or the container integrity is compromised, the product should not be used. Patients should contact their healthcare provider for guidance on continued treatment and replacement of the medication.

The recalled product

Product: Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Manufacturer: Preferred Pharmaceuticals, Inc.
Category: Drug — Topical Solution
Hazard: container-defect
product-leakage
Affected units: 72

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 (1)

Lot #: E1220B

Distribution

Distributed in 3 states:

Same manufacturer · Preferred Pharmaceuticals, Inc.

See all →

Moderate
Preferred Pharmaceuticals Recalls Lidocaine Ointment Due to Content Uniformity Failures
FDA (Drugs) · 2026-10-14
High
Geri-Care artificial tears lubricant eye drops recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Moderate
Ondansetron blister packs recalled because tablets are falling out
FDA (Drugs) · 2025-12-24
Moderate
Clindamycin Hydrochloride Capsules Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-07
High
Ibuprofen Tablets Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-09-04

Same hazard · container defect