Gentell Hydrogel Wound Dressing Recall: CGMP Deviations
Gentell recalls regular 4 oz. Hydrogel Wound Dressing tubes due to CGMP deviations. Check lot numbers and expiration date for affected units.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Gentell, Inc. is recalling its Gentell Hydrogel Wound Dressing REGULAR in 4 oz. tubes due to Current Good Manufacturing Practice (CGMP) deviations. The recall covers specific lots manufactured at their Bristol, PA facility with an expiration date of November 2018. No specific injury mechanism or remedy details are provided in the record. Read more at govinfonow.com/recall/42123-gentell-hydrogel-wound-dressing-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/42123-gentell-hydrogel-wound-dressing-recall-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-0243-2017
Cite this page
“Gentell Hydrogel Wound Dressing Recall: CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42123-gentell-hydrogel-wound-dressing-recall-cgmp-deviations. Based on FDA recall #D-0243-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0243-2017%22&limit=1).
Why it’s dangerous
The record cites CGMP deviations as the hazard. While this indicates a failure to meet manufacturing quality standards, the specific nature of the deviation and its potential impact on product safety or efficacy is not described in the provided text.
Who’s affected
Consumers who purchased Gentell Hydrogel Wound Dressing REGULAR (4 oz. tube) in the United States before December 15, 2016. Individuals using these specific lots for wound care are potentially affected.
How to tell if you have this one
Look for Gentell Hydrogel Wound Dressing REGULAR in a 4 oz. tube with NDC 61554-111-04. Check the Gen Code and Lot Number against the list: 11240, 1121615, 1121713, 1122215, 1123315, 1125215, 1126515, 1127315, 1130015, 1133615, 1131615, 1136215, 1136415, 1100616, 1102616, 1105516, 1106216, 1106816, 1108816, 1109616, 1110316, 1111816, 1114116, 1116616, 1118716, 1119516, 1121516, 1123116. The expiration date is 11/18.
- Brand
Gentell- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0242-2017 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007; Gentell Hydrogel AG 2X2 (Gen-11260) Lot #: 1121615, 1121713, 1122215; Exp. 11/18 Gentell Hydrogel AG 4X4 (Gen-11460) Lot #: 1123315, 1125215, 1126515; Exp. 11/18 Gentell Hydrogel AG 4X8 (Gen-11860) Lot #: 1127315, 1130015, 1133615; Exp. 11/18 | 3,000 gauzes |
| D-0243-2017 | Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04; 4 oz. tube: Gen Code 11240 Lot #: 1121615, 1121713, 1122215, 1123315, 1125215, 1126515, 1127315, 1130015, 1133615, 1131615, 1136215, 1136415, 1100616, 1102616, 1105516, 1106216, 1106816, 1108816, 1109616, 1110316, 1111816, 1114116, 1116616, 1118716, 1119516, 1121516, 1123116; Exp. 11/18 | unknown |
How this recall unfolded
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The distribution pattern for this recall is listed as the United States.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0243-2017 (December 15, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0243-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.