Clindamycin and Benzoyl Peroxide Gel Recalled for Superpotent Formulation
TOLMAR, Inc. is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, nationwide due to a superpotent (higher-than-intended active ingredient) formulation. The voluntary recall affects three specific lots.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries stated in the source text. The hazard—superpotent formulation—is a drug-strength defect that warrants corrective action but falls short of the criteria for High or above (which require reported harm, high-risk pathogens, or allergen mislabeling).
Plain-English summary
TOLMAR, Inc. is voluntarily recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5% in 25 g jars (Rx only, NDC 0781-7263-68), manufactured at its Fort Collins, Colorado facility. The recall was initiated on November 8, 2021, and classified as Class II by the FDA on December 14, 2021.
The reason for recall is a superpotent drug formulation—meaning the gel contains higher-than-intended concentrations of active ingredients. The affected lots are: Lot #11557C1 (Exp. Date Feb 2022), Lot #11552B1 (Exp. Date Apr 2022), and Lot #12206A1 (Exp. Date Nov 2022).
The product was distributed nationwide within the United States. Consumers currently using affected lots should contact their healthcare provider or pharmacist for guidance. The recall was terminated on September 7, 2022.
The recalled product
- Product
- Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
- Manufacturer
- TOLMAR, Inc.
- Category
- Drug — Topical Anti-acne
- Hazard
- superpotent-formulation
- over-potency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 11557C1
- Exp. Date: Feb 2022
- 11552B1
- Exp. Date Apr 2022
- 12206A1
- Exp. Date: Nov 2022
Distribution
Distributed nationwide across the United States.
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