// Summary
Ten drug recalls posted today, all Class II or pending classification — no Class I actions in this run. Sterility and microbial contamination concerns affect ophthalmic and topical products from three manufacturers, while dissolution failures hit extended-release tablets from three separate firms. A temperature-abuse excursion on a branded oncology implant and a consumer-reported discoloration issue on an Amazon-distributed generic round out the list.
| Total | 10 |
| Class I | 0 |
| Class II | 9 |
| Not Yet Classified | 1 |
// Not Yet Classified
Acetaminophen Caplets — Discoloration
| ID | Not assigned |
| Class | Not Yet Classified |
| Status | Ongoing |
| Product | Acetaminophen Extra Strength 500mg Caplets, 1000-count, NDC 72288-692-01 |
| Manufacturer | Aurobindo Pharma USA Inc (distributed by Amazon.com Services LLC) |
| Reason | Consumer complaints of discolored tablets |
| Filed | 2026-10-07 |
| Effective | 2026-09-18 |
| Location | NJ, United States |
Private-label OTC exposure for Amazon; classification pending will determine notification scope for the 1000-count retail lot.
// Class II — Sterility & Contamination
Benzoyl Peroxide Wash 10% — Microbial Contamination
| ID | D-0879-2026 |
| Class | II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash USP 10%, NDC 0536-1261-63 / NDC 0536-1351-42 |
| Manufacturer | SV Labs Toronto Corporation (dist. Rugby Laboratories) |
| Reason | Microbial contamination of topical product |
| Filed | 2026-10-07 |
| Effective | 2026-09-01 |
| Location | IL only; Canada (country of origin) |
Benzoyl Peroxide Wash 5% — Microbial Contamination
| ID | D-0878-2026 |
| Class | II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash USP 5%, NDC 0536-1259-63 |
| Manufacturer | SV Labs Toronto Corporation (dist. Rugby Laboratories) |
| Reason | Microbial contamination of topical product |
| Filed | 2026-10-07 |
| Effective | 2026-09-01 |
| Location | IL only; Canada |
Companion lots from the same Toronto-based manufacturer — both washes share a root-cause investigation; firms distributing Rugby-labeled benzoyl peroxide should check lot numbers against both recalls.
FOCUS PI Hypromellose — Lack of Sterility Assurance
| ID | D-0874-2026 |
| Class | II |
| Status | Ongoing |
| Product | Hypromellose 0.7% ophthalmic solution, NDC 82724-007-19 |
| Manufacturer | Aurolab Trust (for Covalent Management, Inc.) |
| Reason | Lack of assurance of sterility |
| Filed | 2026-10-07 |
| Effective | 2026-09-17 |
| Location | VA; India (country of origin) |
TRP Gentle Eyes Lubricant Drops — Lack of Sterility Assurance
| ID | D-0860-2026 |
| Class | II |
| Status | Ongoing |
| Product | Carboxymethylcellulose sodium 0.5% eye drops, NDC 17312-430-15 |
| Manufacturer | Sterling Pharmaceutical Services LLC (for TRP Company, Inc.) |
| Reason | Lack of assurance of sterility |
| Filed | 2026-09-30 |
| Effective | 2026-08-20 |
| Location | IL, United States |
Two separate sterility-assurance recalls on sterile ophthalmic products this cycle; both are nationwide-distributed single-dose or multi-use eye products — a reminder that USP 71 sterility testing gaps remain a recurring enforcement trigger.
// Class II — Manufacturing & Dissolution Defects
Estradiol Gel — Defective Container
| ID | D-0873-2026 |
| Class | II |
| Status | Ongoing |
| Product | Estradiol Gel 0.1% (0.25 mg packets), NDC 69238-2452-3 |
| Manufacturer | Amneal Pharmaceuticals, LLC |
| Reason | Packets found empty or partially full |
| Filed | 2026-10-07 |
| Effective | 2026-09-08 |
| Location | NJ, United States (nationwide distribution) |
Zoladex Implant — Temperature Abuse
| ID | D-0875-2026 |
| Class | II |
| Status | Ongoing |
| Product | Zoladex (goserelin) 3.6 mg implant syringe, NDC 70720-950-36 |
| Manufacturer | TerSera Therapeutics LLC (mfg. AstraZeneca UK, Product of Switzerland) |
| Reason | Sat in non-temperature-controlled trailer at ambient outdoor conditions for 25.5 hours |
| Filed | 2026-10-07 |
| Effective | 2026-08-31 |
| Location | IL, United States (nationwide) |
Oncology-supportive-care product with a cold-chain lapse; providers holding Lot YN0099 should verify storage records before administration.
Paroxetine ER Tablets — Failed Dissolution
| ID | D-0877-2026 |
| Class | II |
| Status | Ongoing |
| Product | Paroxetine Extended-Release Tablets 37.5mg, NDC 60505-1318-3 |
| Manufacturer | Apotex Corp. (mfg. Apotex Inc., Canada) |
| Reason | Failed dissolution specifications |
| Filed | 2026-10-07 |
| Effective | 2026-09-23 |
| Location | FL, United States (nationwide) |
Ranolazine ER Tablets — Failed Dissolution
| ID | D-0010-2027 |
| Class | II |
| Status | Ongoing |
| Product | Ranolazine Extended-Release Tablets 1000 mg, NDC 27241-126-02 |
| Manufacturer | Ajanta Pharma USA Inc |
| Reason | Failed dissolution specifications (below spec) |
| Filed | 2026-10-07 |
| Effective | 2026-09-17 |
| Location | NJ, United States (nationwide) |
Buprenorphine HCl Injection — Crystallization
| ID | D-0876-2026 |
| Class | II |
| Status | Ongoing |
| Product | Buprenorphine HCl Injection 0.3 mg/mL, 5x1mL vials, NDC 42023-179-05 |
| Manufacturer | Par Health USA, LLC (for Endo USA) |
| Reason | Crystallization |
| Filed | 2026-10-07 |
| Effective | 2026-09-08 |
| Location | MI, United States (nationwide); six lots affected |
Crystallization in an injectable opioid-agonist product poses dosing and particulate-injection risk; facilities should quarantine all six listed lots pending reconciliation.
