G & W Labs Recalls Clindamycin Topical Solution Due to CGMP Deviations
G & W Laboratories recalls specific lots of Clindamycin Phosphate Topical Solution USP, 1% due to the use of an expired active ingredient during manufacturing.
Use caution until it’s fixed
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Contact the company
What happened, in plain English
G & W Laboratories, Inc. is recalling Clindamycin Phosphate Topical Solution USP, 1%, because Good Manufacturing Practice (CGMP) deviations occurred during production. Specifically, an expired active ingredient was used in the manufacture of certain lots. The recall affects 39,816 bottles distributed nationwide in the USA. Read more at govinfonow.com/recall/41862-g-w-labs-recalls-clindamycin-topical-solution-due-to-cgmp.
Source Summary by GovInfoNow · govinfonow.com/recall/41862-g-w-labs-recalls-clindamycin-topical-solution-due-to-cgmp · Updated October 11, 2026 · FDA enforcement record: FDA #D-0519-2017
Cite this page
“G & W Labs Recalls Clindamycin Topical Solution Due to CGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41862-g-w-labs-recalls-clindamycin-topical-solution-due-to-cgmp. Based on FDA recall #D-0519-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0519-2017%22&limit=1).
Why it’s dangerous
The use of an expired active ingredient in manufacturing violates CGMP standards, which could result in the product not meeting its labeled strength or quality specifications. While the record does not specify immediate physical injury risks like burns or toxicity, using a drug with potentially degraded potency may lead to ineffective treatment of the condition it is prescribed for.
Who’s affected
Consumers who purchased Clindamycin Phosphate Topical Solution USP, 1% from pharmacies or healthcare providers across the United States. Individuals using these specific lots may be at risk if the medication's potency is compromised due to the expired ingredient.
How to tell if you have this one
Check if you have Clindamycin Phosphate Topical Solution USP, 1% manufactured by G & W Laboratories, Inc. Look for NDC numbers 0472-0987-91 (30 mL bottles) or 0472-0987-92 (60 mL bottles). Affected lots include: a) 032100042, 032100043, 032100044, 032100045 (Exp 06/17); b) 032100038, 032100039, 032100040, 032100041 (Exp 05/17); and c) 032100046, 032100047, 032100048, 032100049 (Exp 06/17).
- Brand
G & W Laboratories- Category
Drug
What to do — step by step
Check Your Lot Numbers
Verify if your bottle matches the NDC numbers and lot numbers listed in the recall record.
Contact Your Pharmacist
If you have one of the recalled lots, contact the pharmacy where you purchased it for further instructions on disposal or replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” 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.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0519-2017 (February 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0519-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.