Gentell Hydrogel Wound Dressing Regular Recall: FDA Class II

Why it was recalled

CGMP Deviations

Product description

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

Lot numbers, UPCs & expiration codes

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

Where it was sold

United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0243-2017
Classification: Class II
Status: Terminated
Recall initiated: Dec 15, 2016
FDA report date: Jan 11, 2017
Quantity: unknown
Recall type: Voluntary: Firm initiated
Recalling firm: Gentell, Inc

Original FDA data

Every field from FDA enforcement report D-0243-2017, exactly as published.

Show all FDA fields

City: Bristol
State: PA
Status: Terminated
Country: United States
Event ID: 75982
Address: 2701 Bartram Rd
Code information: 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
Postal code: 19007-6810
Report date: Jan 11, 2017
Product type: Drugs
Recall number: D-0243-2017
Classification: Class II
Recalling firm: Gentell, Inc
Product quantity: unknown
Termination date: Feb 16, 2018
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04
Distribution pattern: United States
Recall initiation date: Dec 15, 2016
Initial firm notification: E-Mail
Center classification date: Jan 2, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0243-2017, published Jan 11, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Gentell Hydrogel Wound Dressing REGULAR Recall

Summary