The FDA Desk2026-10-19October 19, 2026
FDA Recall Digest — 10 Drug Recalls Posted, No Class I Actions
// Summary
Ten drug recalls were logged today, none rising to Class I. The bulk involve microbial contamination, sterility assurance failures, dissolution specification misses, and packaging/stability defects across generic and branded prescription products. One Amazon-distributed OTC acetaminophen lot remains pending FDA classification.
| Total | 10 |
| Class I | 0 |
| Class II | 9 |
| Not Yet Classified | 1 |
// Class II — Sterility & Microbial Contamination
Benzoyl Peroxide Wash 10%
| 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, Livonia, MI) |
| Reason | Microbial contamination of topical product |
| Distribution | IL only |
| Filed | 2026-10-07 |
Benzoyl Peroxide Wash 5%
| 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, Livonia, MI) |
| Reason | Microbial contamination of topical product |
| Distribution | IL only |
| Filed | 2026-10-07 |
Both benzoyl peroxide recalls share the same Canadian contract manufacturer and notification method (email), suggesting a common upstream quality failure worth monitoring for further lot expansion.
FOCUS PI Hypromellose Ophthalmic Solution
| ID | D-0874-2026 |
| Class | II |
| Status | Ongoing |
| Product | FOCUS PI Hypromellose 0.7%, sterile 10 mL vials (NDC 82724-007-19) |
| Manufacturer | Aurolab Trust (India), mfg. for Covalent Management Inc., Manassas, VA |
| Reason | Lack of assurance of sterility |
| Distribution | VA |
| Filed | 2026-10-07 |
TRP Gentle Eyes Lubricant Eye Drops
| ID | D-0860-2026 |
| Class | II |
| Status | Ongoing |
| Product | Carboxymethylcellulose sodium 0.5% eye drops, 15 mL (NDC 17312-430-15) |
| Manufacturer | Sterling Pharmaceutical Services LLC for TRP Company, Inc., Reno, NV |
| Reason | Lack of assurance of sterility |
| Distribution | USA Nationwide |
| Filed | 2026-09-30 |
// Class II — Manufacturing, Stability & Packaging Defects
Estradiol Gel
| ID | D-0873-2026 |
| Class | II |
| Status | Ongoing |
| Product | Estradiol Gel 0.1%, 0.25 mg packets, 30-ct carton (NDC 69238-2452-3) |
| Manufacturer | Amneal Pharmaceuticals, LLC, Bridgewater, NJ |
| Reason | Defective container — packets found empty or partially full |
| Distribution | Nationwide USA |
| Filed | 2026-10-07 |
Zoladex (goserelin) Implant
| ID | D-0875-2026 |
| Class | II |
| Status | Ongoing |
| Product | Zoladex 3.6 mg single-use syringe (NDC 70720-950-36) |
| Manufacturer | TerSera Therapeutics LLC (mfg. AstraZeneca UK Limited, Product of Switzerland) |
| Reason | Temperature abuse — product sat in non-climate-controlled FedEx trailer for 25.5 hours |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 |
Paroxetine Extended-Release Tablets
| ID | D-0877-2026 |
| Class | II |
| Status | Ongoing |
| Product | Paroxetine ER 37.5 mg, 30-ct bottle (NDC 60505-1318-3) |
| Manufacturer | Apotex Inc./Apotex Corp., Weston, FL |
| Reason | Failed dissolution specifications |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 |
Buprenorphine Hydrochloride Injection
| ID | D-0876-2026 |
| Class | II |
| Status | Ongoing |
| Product | Buprenorphine HCl Injection 0.3 mg/mL, 5x1 mL vials (NDC 42023-179-05) |
| Manufacturer | Par Health USA, LLC for Endo USA, Malvern, PA |
| Reason | Crystallization |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 |
Ranolazine Extended-Release Tablets
| ID | D-0010-2027 |
| Class | II |
| Status | Ongoing |
| Product | Ranolazine ER 1000 mg, 60-ct bottle (NDC 27241-126-02) |
| Manufacturer | Ajanta Pharma USA Inc., Bridgewater, NJ |
| Reason | Failed dissolution specifications — below spec |
| Distribution | Nationwide USA |
| Filed | 2026-10-07 |
// Not Yet Classified
Amazon-Branded Acetaminophen Extra Strength
| Class | Not Yet Classified |
| Status | Ongoing |
| Product | Acetaminophen Extra Strength 500 mg caplets, 1000-ct bottle (NDC 72288-692-01) |
| Manufacturer | Aurobindo Pharma USA Inc. (dist. Amazon.com Services LLC) |
| Reason | Discoloration — consumer complaints on discolored tablets |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 |
A high-volume e-commerce OTC lot pending FDA risk classification; given nationwide distribution via Amazon, pharmacy and retail compliance teams should pull affected lot ACD124048A pending final determination.