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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Akorn, Inc.: Clindamycin Phosphate Topical Solution Recalled for Impurity Specifications

Agency Publication Date: November 27, 2018
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Summary

Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL), which is a prescription medication used to treat acne. The recall was initiated because testing showed the product failed to meet specifications for impurities and degradation, meaning the chemical composition of the medicine changed over time. Approximately 58,393 jars across ten specific lot numbers are affected by this nationwide recall. If you have this medication, you should contact your doctor or pharmacist to discuss your treatment and learn how to obtain a refund.

Risk

The product has observed 'out of specification' results for impurities and degradation, which means the medication may not maintain its required strength or quality through its expiration date. While this recall is classified as low risk, using a degraded medication may result in reduced effectiveness for treating your condition.

What You Should Do

  1. Check your jar of Clindamycin Phosphate Topical Solution USP, 1% (60 pledget applicators per jar) for NDC number 61748-0201-60.
  2. Verify the lot number and expiration date on the packaging. Affected lot numbers include 2530200, 2530300, 2530400, 2607300, 2607400, 2607500, 2607600, 2615800 (all Exp 1/31/2019), and 2630200, 2630300 (both Exp 2/28/2019).
  3. Contact your healthcare provider or pharmacist immediately to inform them you have a recalled product and to seek guidance on continuing your treatment.
  4. Return any unused portions of the medication to the pharmacy where you purchased it for a refund and to ensure proper disposal.
  5. Contact Akorn, Inc. at their distributor location in Decatur, Illinois, or your original point of purchase for further instructions regarding this voluntary recall.
  6. For additional questions or to report adverse reactions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall return and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar
Model:
NDC# 61748-0201-60
Recall #: D-1208-2019
Lot Numbers:
2530200 (Exp 1/31/2019)
2530300 (Exp 1/31/2019)
2530400 (Exp 1/31/2019)
2607300 (Exp 1/31/2019)
2607400 (Exp 1/31/2019)
2607500 (Exp 1/31/2019)
2607600 (Exp 1/31/2019)
2615800 (Exp 1/31/2019)
2630200 (Exp 2/28/2019)
2630300 (Exp 2/28/2019)
Date Ranges: Expiration date: 1/31/2019, Expiration date: 2/28/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81426
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 58,393 jars
Distributed To: Nationwide
Agency Last Updated: April 23, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.