CLASS III ONGOING Drug recall · Reported 13 Mar 2024 · FDA Enforcement Report
Clindamycin Phosphate Topical Solution recalled
Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution USP, 1%, distributed nationwide in the US. The recall was initiated on 20 Feb 2024 and the FDA has classified it as Class III.
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-0365-2024
- FDA event ID
- 94066
- Recalling firm
- Contract Pharmaceuticals Limited Canada, Mississauga
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 20 Feb 2024
- FDA classified
- 1 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 20 Feb 2024 | Recall initiated by company | |
| 1 Mar 2024 | Classified by FDA | +10 days |
| 13 Mar 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
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 Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
Where it was distributed
Nationwide in the U.S. and Puerto Rico
Questions about this recall
Why was it recalled?
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Which lots are affected?
Lot #: 119874; Exp 06/30/2025
Where was it sold?
Nationwide in the U.S. and Puerto Rico
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94066This product is part of a recall event; the main page for the event is Clindamycin Phosphate, Topical Solution recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Clindamycin Phosphate, Topical Solution recalled | Contract Pharmaceuticals Limited Canada | Potency & Assay | Nationwide |
More recalls from Contract Pharmaceuticals Limited Canada
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Clindamycin Phosphate, Topical Solution recalled | Contract Pharmaceuticals Limited Canada | Potency & Assay | Nationwide |
| Drug | CLASS III | Clindamycin Phosphate Topical Solution recalled | Contract Pharmaceuticals Limited Canada | Packaging Defects | Nationwide |
Other Clindamycin recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 600 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clindamycin Injection USP in 5% Dextrose, 900 mg recalledClindamycin Phosphate | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |