// Summary
Ten recalls posted today, none rising to Class I. Nine carry a Class II designation spanning sterility failures, dissolution defects, temperature excursions, and microbial contamination; one Amazon-branded acetaminophen lot remains Not Yet Classified pending FDA review. Two Rugby Laboratories benzoyl peroxide products from the same Toronto-based contract manufacturer account for a cluster of the sterility-related actions.
| Total | 10 |
| Class I | 0 |
| Class II | 9 |
| Not Yet Classified | 1 |
// Class II
Benzoyl Peroxide Wash 10%
| ID | D-0879-2026 |
| Class | II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash, USP, 10%, 5 FL OZ and 8.5 FL OZ bottles, NDC 0536-1261-63 / 0536-1351-42 |
| Manufacturer | SV Labs Toronto Corporation (distributed by Rugby Laboratories) |
| Reason | Microbial contamination of topical product |
| Distribution | IL only |
| Filed | 2026-10-07 |
| Effective | 2026-09-01 |
Benzoyl Peroxide Wash 5%
| ID | D-0878-2026 |
| Class | II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ bottle, NDC 0536-1259-63 |
| Manufacturer | SV Labs Toronto Corporation (distributed by Rugby Laboratories) |
| Reason | Microbial contamination of topical product |
| Distribution | IL only |
| Filed | 2026-10-07 |
| Effective | 2026-09-01 |
Both Rugby-labeled washes trace to the same Canadian contract manufacturer and share a contamination root cause — worth watching for a broader firm-level action.
Estradiol Gel 0.1%
| ID | D-0873-2026 |
| Class | II |
| Status | Ongoing |
| Product | Estradiol Gel, 0.1%, 0.25 mg, 30-packet carton, NDC 69238-2452-3 |
| Manufacturer | Amneal Pharmaceuticals, LLC |
| Reason | Defective container — packets found empty or partially full |
| Distribution | Nationwide (USA) |
| Filed | 2026-10-07 |
| Effective | 2026-09-08 |
FOCUS PI Hypromellose 0.7% Vials
| ID | D-0874-2026 |
| Class | II |
| Status | Ongoing |
| Product | FOCUS PI Hypromellose 0.7% Formula, sterile vials, NDC 82724-007-19 |
| Manufacturer | Aurolab Trust (India), for Covalent Management, Inc. |
| Reason | Lack of assurance of sterility |
| Distribution | VA |
| Filed | 2026-10-07 |
| Effective | 2026-09-17 |
Zoladex 3.6 mg Implant
| ID | D-0875-2026 |
| Class | II |
| Status | Ongoing |
| Product | Zoladex (goserelin) implant, 3.6 mg, single-use syringe, NDC 70720-950-36 |
| Manufacturer | TerSera Therapeutics LLC (mfd. by AstraZeneca UK, product of Switzerland) |
| Reason | Temperature abuse — product held 25.5 hours in non-temperature-controlled FedEx trailer |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 |
| Effective | 2026-08-31 |
A cold-chain lapse on a hormone-sensitive oncology product warrants close provider follow-up on affected lot YN0099.
Paroxetine Extended-Release Tablets
| ID | D-0877-2026 |
| Class | II |
| Status | Ongoing |
| Product | Paroxetine ER Tablets, 37.5 mg, 30-count bottle, NDC 60505-1318-3 |
| Manufacturer | Apotex Corp. (mfd. by Apotex Inc., Canada) |
| Reason | Failed dissolution specifications |
| Distribution | US Nationwide |
| Filed | 2026-10-07 |
| Effective | 2026-09-23 |
Buprenorphine Hydrochloride Injection
| ID | D-0876-2026 |
| Class | II |
| Status | Ongoing |
| Product | Buprenorphine HCl Injection, 0.3 mg/mL, 5x1 mL single-dose vials, NDC 42023-179-05 |
| Manufacturer | Par Health USA, LLC (for Endo USA) |
| Reason | Crystallization |
| Distribution | US Nationwide |
| Filed | 2026-10-07 |
| Effective | 2026-09-08 |
Six lots implicated, spanning expirations from October 2026 through May 2027 — a broad window for a controlled-substance product.
Ranolazine Extended-Release Tablets
| ID | D-0010-2027 |
| Class | II |
| Status | Ongoing |
| Product | Ranolazine ER Tablets, 1000 mg, 60-count bottle, NDC 27241-126-02 |
| Manufacturer | Ajanta Pharma USA Inc. |
| Reason | Failed dissolution specifications (below specification) |
| Distribution | Nationwide (US) |
| Filed | 2026-10-07 |
| Effective | 2026-09-17 |
TRP Gentle Eyes Lubricant Eye Drops
| ID | D-0860-2026 |
| Class | II |
| Status | Ongoing |
| Product | Gentle Eyes Lubricant Eye Drops, CMC sodium 0.5%, 0.5 FL OZ bottles, NDC 17312-430-15 |
| Manufacturer | Sterling Pharmaceutical Services LLC (for TRP Company, Inc.) |
| Reason | Lack of assurance of sterility |
| Distribution | USA Nationwide |
| Filed | 2026-09-30 |
| Effective | 2026-08-20 |
// Not Yet Classified
Amazon Acetaminophen Extra Strength Caplets
| Product | Acetaminophen, Extra Strength, 500 mg, 1000-count bottle, NDC 72288-692-01 |
| Manufacturer | Aurobindo Pharma USA Inc. (distributed by Amazon.com Services LLC; made in India) |
| Reason | Discoloration — consumer complaints of discolored tablets |
| Distribution | US Nationwide |
| Filed | 2026-10-07 |
| Effective | 2026-09-18 |
A classification remains pending; given the high-volume consumer distribution channel, FDA's severity determination should be watched closely for downstream labeling or retailer notice obligations.
