UnratedDrug recall · FDA · Published November 8, 2021
Tolmar Clindamycin Gel Recall: Superpotent Drug Risk
Tolmar recalls Clindamycin and Benzoyl Peroxide Gel 1%/5% 25g jars (Rx only) due to superpotent drug risk. Check NDC 0781-7263-68 and lot numbers for affected products.
📍Recalling firmTOLMAR, Inc.1201 Cornerstone Dr · Windsor, CO 80550-5547
✎ GovInfoNow plain-language explainer
Tolmar is recalling Clindamycin and Benzoyl Peroxide Gel products because they contain a superpotent drug that could cause serious harm if misused. This recall affects prescription-only jars with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/35573-tolmar-clindamycin-gel-recall-superpotent-drug-risk.
“Tolmar Clindamycin Gel Recall: Superpotent Drug Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35573-tolmar-clindamycin-gel-recall-superpotent-drug-risk. Based on FDA recall #D-0282-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0282-2022%22&limit=1).
The FDA announced on November 8, 2021, that Tolmar, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel due to superpotent drug risks. The recall affects specific lots of the 25 g jars distributed nationwide.
How to tell if you have it
Brand: Tolmar
Product: Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars
NDC: 0781-7263-68
Lot #11557C1, Exp. Date: Feb 2022
Lot #11552B1, Exp. Date Apr 2022
Lot #12206A1, Exp. Date: Nov 2022
Manufacturer: TOLMAR Inc., Fort collins, CO 80526
The hazard
The product is classified as a superpotent drug according to the FDA. The recall was initiated voluntarily by the firm.
Context
GovInfoNow's records show Tolmar, Inc. has had three other recalls since September 23, 2013. Other recent recalls of similar products include Sandoz Ketoconazole Shampoo Recall (September 23, 2013) and Tolmar Naftifine Gel Recall (July 11, 2022). Additional context includes the Tolmar Eligard injection recall on September 12, 2023, and recent clindamycin-related recalls by Baxter (August 6, 2026), SUN PHARMACEUTICAL (November 26, 2025), and Bell Pharmaceuticals (June 25, 2026).
How to tell if you have this one
Check for NDC 0781-7263-68 and lot numbers 11557C1 (expires Feb 2022), 11552B1 (expires Apr 2022), or 12206A1 (expires Nov 2022) on the product label. The product is prescription-only and sold in 25g jars.
Brand
Tolmar
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for NDC 0781-7263-68 and lot numbers 11557C1, 11552B1, or 12206A1 on the gel jar.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0282-2022 (November 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0282-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.