CLASS II Drug recall · Reported 22 Dec 2021 · FDA Enforcement Report
Clindamycin and Benzoyl Peroxide Gel, 1%/5% recalled by TOLMAR
TOLMAR is recalling Clindamycin and Benzoyl Peroxide Gel, 1%/5%, distributed nationwide in the US. The recall was initiated on 8 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0282-2022
- FDA event ID
- 88910
- Recalling firm
- TOLMAR, Windsor, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2021
- FDA classified
- 14 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 8 Nov 2021 | Recall initiated by company | |
| 14 Dec 2021 | Classified by FDA | +36 days |
| 22 Dec 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Clindamycin and Benzoyl Peroxide Gel, 1%/5% recalled?
Yes. TOLMAR recalled Clindamycin and Benzoyl Peroxide Gel, 1%/5% on 8 Nov 2021. The recall is Class II and its status is Terminated. Recall number D-0282-2022.
Why was it recalled?
Superpotent Drug
Which lots are affected?
Lot #: 11557C1, Exp. Date: Feb 2022; 11552B1, Exp. Date Apr 2022; 12206A1, Exp. Date: Nov 2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TOLMAR
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|---|---|---|---|---|---|
| Drug | CLASS III | Eligard (leuprolide acetate) for injectable suspension recalledEligard | Tolmar | Sterility | Nationwide |
| Drug | CLASS II | Naftifine Hydrochloride Gel recalled by Tolmar | Tolmar | Potency & Assay | KY |
| Drug | CLASS III | Ketoconazole Shampoo recalled by Tolmar | Tolmar | Potency & Assay | Nationwide |