Clindamycin Solution (G & W Laboratories) - Expired Ingredient (2017)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.
Brand
G & W Laboratories, Inc.
Lot Codes / Batch Numbers
Lot #'s: a) 032100042, 032100043, 032100044, 032100045, Exp 06/17, b) 032100038, 032100039, 032100040, 032100041, Exp 05/17, 032100046, 032100047, 032100048, 032100049, Exp 06/17.
Products Sold
Lot #'s: a) 032100042, 032100043, 032100044, 032100045, Exp 06/17; b) 032100038, 032100039, 032100040, 032100041, Exp 05/17; 032100046, 032100047, 032100048, 032100049, Exp 06/17.
G & W Laboratories, Inc. is recalling Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-09 due to CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026