// Summary
No CPSC consumer-product recall data could be retrieved this run due to a provider outage; the FDA queue carries ten drug recalls, nine classified Class II and one pending classification, none of which cite injury or death. Recurring failure modes include sterility assurance lapses, dissolution/potency failures, and physical defects (empty packets, crystallization, discoloration). Two items from the same Canadian manufacturer (SV Labs Toronto) account for both benzoyl peroxide recalls.
| Total | 10 |
| Class I | 0 |
| Class II | 9 |
| Not Yet Classified | 1 |
| CPSC items | 0 (source unavailable) |
| Injury/Death cited | 0 |
// CPSC Consumer Product Recalls
Source unavailable this run — the CPSC recall provider failed on open. No consumer product recall data to report; will retry next cycle.
// FDA Recalls
Benzoyl Peroxide Wash, USP 10%
| ID | D-0879-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash, USP, 10%, 5 FL OZ (NDC 0536-1261-63) and 8.5 FL OZ (NDC 0536-1351-42) |
| Manufacturer | SV Labs Toronto Corporation (distributed by Rugby Laboratories, Livonia, MI) |
| Reason | Microbial contamination of topical product |
| Lot/Exp | 0575-01-366 (Jan-27); 0565-02-336 (Feb-27); 0645-02-355, 0575-02-336 (Feb-27); 0565-12-317 (Dec-26) |
| Distribution | IL only |
| Filed | 2026-10-07 | Initiated: 2026-09-01 |
Benzoyl Peroxide Wash, USP 5%
| ID | D-0878-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ, NDC 0536-1259-63 |
| Manufacturer | SV Labs Toronto Corporation (distributed by Rugby Laboratories) |
| Reason | Microbial contamination of topical product |
| Lot/Exp | 0525-02-345 (02/2027) |
| Distribution | IL only |
| Filed | 2026-10-07 | Initiated: 2026-09-01 |
Both benzoyl peroxide recalls trace to the same Canadian contract manufacturer; pharmacies holding Rugby-labeled stock in Illinois should quarantine affected lots pending further guidance.
Estradiol Gel, 0.1%
| ID | D-0873-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Estradiol Gel, 0.25 mg packets, 30-ct carton, NDC 69238-2452-3 |
| Manufacturer | Amneal Pharmaceuticals, LLC |
| Reason | Defective container — packets found empty or partially full |
| Lot/Exp | 245226005B (04/30/2028) |
| Distribution | Nationwide, USA |
| Filed | 2026-10-07 | Initiated: 2026-09-08 |
FOCUS PI Hypromellose 0.7% Ophthalmic Formula
| ID | D-0874-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Sterile ophthalmic vials, 0.3 FL OZ (10 mL), NDC 82724-007-19 |
| Manufacturer | Aurolab Trust (manufactured for Covalent Management, Inc.) |
| Reason | Lack of assurance of sterility |
| Lot/Exp | 6B093FI (04/01/28); 6F511F1 (05/15/28) |
| Distribution | VA |
| Filed | 2026-10-07 | Initiated: 2026-09-17 |
Zoladex (goserelin) Implant, 3.6 mg
| ID | D-0875-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Single-use syringe implant, NDC 70720-950-36 |
| Manufacturer | TerSera Therapeutics LLC (by AstraZeneca UK Limited) |
| Reason | Temperature abuse — product in non-temperature-controlled FedEx trailer for 25.5 hours at ambient outdoor conditions |
| Lot/Exp | YN0099 (01/31/2028) |
| Distribution | USA Nationwide |
| Filed | 2026-10-07 | Initiated: 2026-08-31 |
Paroxetine Extended-Release Tablets, 37.5 mg
| ID | D-0877-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | 30-count bottle, NDC 60505-1318-3 |
| Manufacturer | Apotex Inc./Apotex Corp. |
| Reason | Failed dissolution specifications |
| Lot/Exp | TY9495 (05/2027) |
| Distribution | US Nationwide |
| Filed | 2026-10-07 | Initiated: 2026-09-23 |
Buprenorphine Hydrochloride Injection, 0.3 mg/mL
| ID | D-0876-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | 5x1 mL single-dose vials, NDC 42023-179-05 |
| Manufacturer | Par Health USA, LLC (for Endo USA) |
| Reason | Crystallization |
| Lot/Exp | 83912 (10/26), 84234 (11/26), 84990 (11/26), 85003 (12/26), 86443 (01/27), 89909 (05/27) |
| Distribution | US Nationwide |
| Filed | 2026-10-07 | Initiated: 2026-09-08 |
Six lots affected spanning expirations through mid-2027 — pharmacies should check full inventory, not just near-expiry stock.
Ranolazine Extended-Release Tablets, 1000 mg
| ID | D-0010-2027 |
| Class | Class II |
| Status | Ongoing |
| Product | 60-count bottle, NDC 27241-126-02 |
| Manufacturer | Ajanta Pharma USA Inc. |
| Reason | Failed dissolution specifications (below spec) |
| Lot/Exp | DJ25134 (11/30/2028) |
| Distribution | Nationwide, US |
| Filed | 2026-10-07 | Initiated: 2026-09-17 |
TRP Gentle Eyes Lubricant Eye Drops
| ID | D-0860-2026 |
| Class | Class II |
| Status | Ongoing |
| Product | Sterile eye drops, 0.5 FL OZ, NDC 17312-430-15 |
| Manufacturer | Sterling Pharmaceutical Services LLC (for TRP Company, Inc.) |
| Reason | Lack of assurance of sterility |
| Lot/Exp | 3279 (6/30/2027); 3292 (5/31/2027) |
| Distribution | USA Nationwide |
| Filed | 2026-09-30 | Initiated: 2026-08-20 |
Acetaminophen Extra Strength 500mg Caplets (Amazon)
| Class | Not Yet Classified |
| Status | Ongoing |
| Product | 1000-count bottle, NDC 72288-692-01, UPC 1 95515 04888 0 |
| Manufacturer | Aurobindo Pharma USA Inc (distributed by Amazon.com Services LLC) |
| Reason | Discoloration — consumer complaints of discolored tablets |
| Lot/Exp | ACD124048A (11/30/2027) |
| Distribution | US Nationwide |
| Filed | 2026-10-07 | Initiated: 2026-09-18 |
Consumer-facing OTC pain reliever sold via Amazon; broad nationwide distribution and high-visibility retailer warrant monitoring for upgraded classification.
