## Facts

- The United States, on behalf of the Food and Drug Administration, brought a civil enforcement action under the Federal Food, Drug, and Cosmetic Act (FDCA).
- Superpharm Corporation and its president, Norman E. Rubin, manufactured and distributed furosemide in interstate commerce without FDA approval.
- The government treated furosemide as a “new drug” and alleged violations of FDCA provisions barring unapproved new drugs in interstate commerce.
- The court previously entered a temporary restraining order (by consent) prohibiting further manufacture or sale of the drug absent FDA approval, and it remained in effect during the decision.
- After settlement discussions resolved other matters, the parties’ remaining dispute was whether the court could order a recall of drug products already distributed.

## Issues

1. In an enforcement action under FDCA § 302 (21 U.S.C. § 332), does a federal district court have statutory authority to order a recall of drug products unlawfully marketed without FDA approval?
2. If not expressly authorized by statute, does a district court’s general equitable power permit a recall order as ancillary relief to an injunction?

## Decision

- The court denied the government’s request for a recall order.
- The court held that FDCA § 302’s grant of jurisdiction “to restrain violations” did not include authority to compel a recall of products already in commerce.
- The court further held that general equitable powers could not be used to create a recall remedy absent clear statutory authorization and that ordering a recall would be an improper use of judicial power.
- The existing restraint against further manufacture or sale remained operative, but no recall was ordered.

## Legal Principles

- A statutory authorization “to restrain violations” under FDCA § 302 is generally limited to prospective injunctive relief and does not, without more, imply authority to order product recalls.
- Federal courts will not infer recall authority from congressional silence where the statute and its legislative history do not indicate an intent to permit recalls in § 302 actions.
- General equitable authority must operate within statutory limits; equity cannot supply a remedial power that Congress did not confer or that does not fit the statutory scheme.
- A recall is an affirmative, sweeping remedy with significant practical and policy consequences; absent explicit authorization, courts should not impose it in FDCA injunction actions.

## Conclusion

The court held that neither FDCA § 302 nor general equitable power authorized a judicially ordered recall of unapproved drugs already distributed in interstate commerce, limiting relief to restraining further statutory violations.


United States v. Superpharm Corp., 530 F. Supp. 408 (E.D.N.Y. 1981)