Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0773-2022·Announced 2022-04-27

Diclofenac Sodium Topical Solution Recalled Due to Manufacturing Quality Deviations

Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution because the manufacturing firm discontinued its stability study program, a CGMP violation. All products within their expiration dates are affected.

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 without reported hospitalizations, injuries, or illnesses. The recall is precautionary in nature, triggered by manufacturing process deviations and discontinued stability studies rather than confirmed product defects or actual harm. Per the severity rubric, this qualifies as Moderate (Score 2).

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Diclofenac Sodium Topical Solution 1.5% w/w, a generic version of Pennsaid, supplied in 150 ml bottles. The recall affects 528 bottles distributed nationwide. The product is a prescription-only topical anti-inflammatory solution.

The recall was initiated because the manufacturing firm is discontinuing its stability study program, which violates Current Good Manufacturing Practice (CGMP) requirements. Stability studies are required to verify that a pharmaceutical product maintains its quality, strength, and purity throughout its shelf life. All products currently within their expiration dates are included in this recall.

Patients currently taking this medication should contact their prescribing healthcare provider or pharmacist to discuss this recall and explore alternative treatment options.

The recalled product

Product: Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
Manufacturer: Preferred Pharmaceuticals, Inc.
Category: Drug — Topical Anti-inflammatory
Hazard: cgmp-deviation
unverified-stability
Affected units: 528

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 (13)

Lots: E1220B
Exp.: 01/31/2023
F0220M
Exp.: 3/31/2023
F2320A
F3020M
G0920Q
C0821M
Exp.: 1/31/2024
J1920
Exp.: 5/31/2023
E2421j
Exp.: 4/30/2024

Distribution

Distributed nationwide across the United States.

Same manufacturer · Preferred Pharmaceuticals, Inc.

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