Regener-Eyes Files Chapter 11 After FDA Warning Letter and Product Recall

Regener-Eyes, LLC and affiliated entities filed chapter 11 petitions on April 3, 2026, in the U.S. Bankruptcy Court for the Middle District of Florida. The Palm Harbor, Florida-based developer and manufacturer of biologic eye drops listed assets and liabilities each in the $10 million to $50 million range. The petition identifies C. Randall Harrell as the member manager and lists Steven M. Berman of Shumaker, Loop & Kendrick, LLP as debtor's counsel. The filing follows more than three years of escalating FDA enforcement actions against the company's manufacturing operations, including a formal warning letter issued in August 2024 and a voluntary product recall initiated in December 2024.

Debtor(s)	Regener-Eyes, LLC and affiliated entities
Court	U.S. Bankruptcy Court, Middle District of Florida
Case Number	26-02780
Petition Date	April 3, 2026
Estimated Assets	$10 million – $50 million
Estimated Liabilities	$10 million – $50 million
Debtor's Counsel	Steven M. Berman, Shumaker, Loop & Kendrick, LLP

Biologic Eye Drop Products and Distribution Model

Regener-Eyes manufactures preservative-free ophthalmic solutions marketed for dry eye treatment under two product lines: Regener-Eyes Professional (PRO) and Regener-Eyes LITE. Regener-Eyes PRO is formulated for severe ocular surface disease, while Regener-Eyes LITE targets mild to moderate cases. Both products are packaged in 3 mL multi-dose vials and sold through optometry clinics and dry eye specialty practices nationwide. The products are not typically covered by insurance and cost patients approximately $150 to $300 per month out of pocket, placing the per-milliliter price at roughly $29 to $66 compared to an average of approximately $2.29 per milliliter for standard glycerin-based eye drops.

Composition and regulatory classification. The company describes the products as processed from human birth tissue and markets them as tonicity and sodium chloride formulations under an over-the-counter drug monograph. In August 2022, Regener-Eyes received an OTC drug indication to relieve dryness of the eye. The FDA subsequently raised concerns that the products may still contain amniotic fluid, which would classify them as biological products requiring a Biologics License Application rather than OTC monograph status.

Corporate structure and manufacturing. The parent and manufacturing entity, Regenerative Processing Plant, LLC, was incorporated in Florida in 2013. The company operates a drug manufacturing facility at 34176 US Highway 19 N, Palm Harbor, Florida. C. Randall Harrell, M.D., founded Regenerative Processing Plant and serves as its chairman and CEO. Revenue for Regenerative Processing Plant was estimated at $5 million to $10 million, with between 20 and 49 employees. The chapter 11 filing covers Regener-Eyes and affiliated entities. The FDA enforcement actions that preceded the filing targeted the manufacturing facility operated by Regenerative Processing Plant rather than Regener-Eyes directly.

FDA Enforcement Timeline

The FDA's enforcement actions against Regenerative Processing Plant began with untitled letters in 2022 and escalated through an inspection, a formal warning letter, and a product recall over the following two years.

October 2022 untitled letter. The FDA sent an untitled letter to Regener-Eyes, LLC on October 5, 2022, notifying the company that its Regener-Eyes Ophthalmic Solution derived from placental-derived biomaterial appeared to be a biological product requiring a valid biologics license under 42 U.S.C. section 262(a). Products derived from amniotic fluid that are marketed to treat, mitigate, or cure disease require either an approved Biologics License Application or an Investigational New Drug application under FDA regulations. The FDA sent a similar letter to M2 Biologics LLC regarding its StimulEyes product in November 2022. M2 Biologics subsequently removed StimulEyes from the market; Regener-Eyes remained on the market.

April 2023 public safety notification. In April 2023, the FDA issued a public safety notification on amniotic fluid eyedrops, stating that manufacturers were marketing and distributing amniotic fluid eyedrops to treat dry eye disease without required premarket review and approval. The notification stated that no amniotic fluid eyedrops have been FDA-approved for testing, mitigating, or curing eye diseases.

June 2023 facility inspection. The FDA inspected Regenerative Processing Plant's manufacturing facility from June 20 through June 30, 2023. The facility had received three prior FDA inspections in 2015, 2017, and 2020 with no violations noted. The June 2023 inspection resulted in citations for 15 federal regulatory law violations. In December 2023, the FDA posted the inspection results on its Data Dashboard with an Official Action Indicated classification, the most adverse outcome on the agency's inspection scale.

August 2024 warning letter. On August 16, 2024, the FDA issued a formal warning letter to Regenerative Processing Plant citing eight current Good Manufacturing Practice violations. The warning letter found that the company's Regener-Eyes PRO and LITE products were unapproved new drugs marketed with claims about treating dry eyes and were misbranded under federal law. The FDA also found that the company's labeling contained false or misleading statements, including incorrect identification of inactive ingredients and claims of full compliance with the FDA.

December 2024 voluntary recall. In December 2024, Regenerative Processing Plant initiated a voluntary recall of Regener-Eyes Professional (NDC: 82305-003-01) and Regener-Eyes Lite (NDC: 82305-006-01). The recall covered all unexpired products manufactured prior to the June 2023 inspection. The FDA classified the recall as Class II due to lack of sterility assurance, indicating that use of the products may cause temporary or medically reversible adverse health consequences. The company simultaneously announced it had introduced new preservative-free bottles with backflow prevention using what it described as PureFlow Technology with a one-way valve.

Manufacturing Deficiencies Cited by the FDA

The June 2023 inspection and August 2024 warning letter documented specific deficiencies at the Palm Harbor manufacturing facility. The 15 regulatory violations documented in the Form 483 covered sterile processing, quality control, environmental monitoring, product release practices, and record-keeping failures.

Cleanroom and sterility failures. Inspectors found that the facility lacked adequate cleanroom construction and could not establish that manufacturing processes were aseptic. In one cleanroom, inspectors observed that slats had been cut into a wall to simulate unidirectional air flow, which opened into an unmonitored area and allowed the influx of particulate-laden air. Batches of Regener-Eyes PRO and LITE shipped after failed media fills were released for commercial distribution. The facility also lacked environmental monitoring and written equipment cleaning procedures.

Quality control and stability testing. The FDA found that 27% of batches had pH readings between 7.7 and 8.3, yet those products were distributed. Units with out-of-range glycerin content were also released. The company's stated room-temperature storage conditions and 24-month shelf life were not supported by its own stability testing data.

Amniotic fluid content. During the inspection, the company's Chief Strategist said the firm stopped using amniotic fluid in approximately June 2021. However, FDA investigators documented that the company continued receiving amniotic fluid shipments matching manufacturing batch records from products made after that date. If the products still contain amniotic fluid, they would be classified as biological products requiring a Biologics License Application that Regenerative Processing Plant does not hold.

Packaging deficiencies. The Regener-Eyes PRO and LITE products were packaged in multi-dose vials without a backflow prevention mechanism and labeled preservative-free. The FDA found that the container type did not provide adequate protection and did not minimize the hazard of contamination during use.

Filing Posture and Early-Stage Indicators

The chapter 11 petition discloses estimated assets and liabilities each in the $10 million to $50 million range. The petition states that funds will be available for distribution to holders of unsecured claims, indicating the debtors expect some distribution to unsecured creditors.

Debtor's counsel. Steven M. Berman of Shumaker, Loop & Kendrick, LLP represents the debtors. Berman is board certified in both creditors' rights law and business bankruptcy law by the American Board of Certification and has practiced bankruptcy law since 1990. He received his J.D. from the University of Florida Levin College of Law and is admitted to the bars of Florida, California, New York, Texas, the District of Columbia, and Puerto Rico (federal). Berman serves on the board of directors of the American Bankruptcy Institute and the American Board of Certification. Shumaker's Tampa office has handled bankruptcy and restructuring matters in the Middle District of Florida. C. Randall Harrell is identified as the member manager of Regener-Eyes, LLC, and the individual authorized to file the petition on behalf of the entity.

Open items on the early docket. The petition was filed on April 3, 2026. The early docket does not yet include a first day declaration, DIP financing motion, schedules, or disclosure of the debtors' proposed case path. The capital structure, prepetition secured and unsecured debt instruments, and the identity of the largest creditor constituencies have not been disclosed in the petition or early filings. Whether the debtors intend to reorganize as a going concern, pursue a sale under section 363, or seek confirmation of a liquidating plan has not been disclosed.

Key Timeline

Date	Event
October 2022	FDA sends untitled letter to Regener-Eyes, LLC regarding biologics licensing requirements
November 2022	FDA sends untitled letter to M2 Biologics LLC regarding its StimulEyes product
April 2023	FDA issues public safety notification on amniotic fluid eyedrops
June 20–30, 2023	FDA inspects Regenerative Processing Plant's Palm Harbor manufacturing facility; identifies 15 federal regulatory law violations
December 2023	FDA posts inspection results on Data Dashboard with Official Action Indicated classification
August 16, 2024	FDA issues formal warning letter citing eight cGMP violations and finding products are unapproved new drugs
December 2024	Regenerative Processing Plant initiates voluntary recall of Regener-Eyes PRO and LITE; introduces new bottles with backflow prevention
February 2026	FDA recall classification lifted
April 3, 2026	Regener-Eyes, LLC and affiliated entities file chapter 11 petitions in the Middle District of Florida

Frequently Asked Questions

What does Regener-Eyes make?

Regener-Eyes manufactures preservative-free biologic eye drops marketed for dry eye treatment. The two primary products are Regener-Eyes PRO (for severe ocular surface disease) and Regener-Eyes LITE (for mild to moderate cases), which are formulated as ophthalmic solutions and sold through optometry clinics at approximately $150 to $300 per month out of pocket. The products are described as processed from human birth tissue and are manufactured by Regenerative Processing Plant, LLC at the company's Palm Harbor, Florida facility.

Why did Regener-Eyes file chapter 11?

The petition does not specify a single cause. The filing follows more than three years of FDA enforcement actions against the company's manufacturing affiliate, Regenerative Processing Plant, including an October 2022 untitled letter questioning the company's biologics licensing, a June 2023 inspection that cited 15 federal regulatory violations, an August 2024 warning letter citing eight cGMP violations, and a December 2024 voluntary product recall.

Will unsecured creditors receive a distribution?

The chapter 11 petition states that funds are expected to be available for distribution to holders of unsecured claims. Specific recovery amounts and the mechanism for distribution have not yet been disclosed in the early docket.

What court is handling the case?

The case is pending in the U.S. Bankruptcy Court for the Middle District of Florida under case number 26-02780.

Who represents the debtors?

Steven M. Berman of Shumaker, Loop & Kendrick, LLP serves as counsel for the debtors. Berman is board certified in creditors' rights law and business bankruptcy law by the American Board of Certification and has practiced bankruptcy law in Florida since 1990.

What is the status of the Regener-Eyes product recall?

The voluntary recall initiated in December 2024 covered all unexpired Regener-Eyes PRO and LITE products manufactured prior to the June 2023 FDA inspection. The FDA classified the recall as Class II due to lack of sterility assurance. The company stated that the recall was lifted in February 2026 and that it had introduced replacement bottles with backflow prevention.

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