WEDGEWOOD VILLAGE PHARMACY, LLC v. U.S. FOOD AND DRUG ADMINISTRATION, 1:22-cv-02649

Plaintiff Wedgewood Village Pharmacy is a veterinary 503A compounding pharmacy that discovered mold in a Twist‑a‑Dose product and initiated a voluntary recall in Feb 2022.
The FDA inspected Wedgewood’s Swedesboro facility from March 14–24, 2022, issued a Form 483 reporting observations (allegedly including vermin and dead insects), and raised concerns about unresolved mold contamination.
On April–May 2022 the FDA recommended a broad recall of nonsterile human‑ and animal‑health compounds; Wedgewood proposed a targeted recall and refused the FDA’s demand to recall by May 5.
Wedgewood sued and sought to enjoin the FDA from issuing a Section 705(b) notice or any press release about the inspection, alleging (1) APA claims (arbitrary and capricious and misapplication of standards) and (2) First Amendment retaliation.
The FDA opposed, arguing no final agency action had occurred, any notice/publication was speculative, the FDA acted within its authority, and the public interest favored disclosure.
The district court denied further injunctive relief and lifted a temporary restraining order, holding the matter not ripe for review (no final agency action), the threatened publications were speculative, and the First Amendment claim required factual development.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Ripeness / final agency action under APA	The imminent Section 705(b) notice or press release is a reviewable, final agency action and ripe for review	No notice or press release has been issued; contents unknown; thus no final agency action and review is premature	Not ripe; no final agency action for APA review; injunctive relief denied
APA arbitrary and capricious / misapplication of standards	FDA acted arbitrarily, failed to explain standards and misapplied regulatory standards to a 503A compounder	FDA had authority to inspect and to recommend/publicize recall; applied proper standards	Plaintiff not shown likely success; merits not reached because review is premature
First Amendment retaliation	Notice/press release would be retaliatory against Wedgewood’s protected challenges to FDA actions	No evidence of retaliatory motive or but‑for causation; claim speculative	Claim premature; requires factual development/discovery; injunctive relief denied
Irreparable harm & balance of equities/public interest	Publication will cause irreparable reputational and business harm and disrupt patient care; status quo should be preserved	Harms are speculative; any publicity already resulted from litigation; public interest favors informing public of health risks	Irreparable harm not established; public interest favors FDA disclosure; injunction denied

Lance v. Coffman, 549 U.S. 437 (2007) (Article III case or controversy requirement)
Aetna Life Ins. Co. v. Haworth, 300 U.S. 227 (1937) (actual, concrete controversy requirement)
Abbott Laboratories v. Gardner, 387 U.S. 136 (1967) (ripeness and final agency action framework)
Lujan v. National Wildlife Federation, 497 U.S. 871 (1990) (review limited to final agency actions that have concrete effects)
Reilly v. City of Harrisburg, 858 F.3d 173 (3d Cir. 2017) (preliminary injunction factors and balancing approach)