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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

RemedyRepack Clindamycin HCl Capsules Recalled for Manufacturing Deviations

Agency Publication Date: April 18, 2025
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Summary

RemedyRepack Inc. is recalling 1,858 units of Clindamycin HCl (300 mg) capsules because the medication was processed under conditions that deviated from Current Good Manufacturing Practice (CGMP) standards. The prescription antibiotic was repackaged into 30-count blister cards at the company's facility in Indiana, Pennsylvania. Because these standards were not met, the manufacturer cannot guarantee the drug's safety, quality, or effectiveness.

Risk

Failure to follow proper manufacturing and packaging procedures can result in medication that is contaminated, ineffective, or of inconsistent quality. While no specific injuries have been reported, using medication that does not meet safety standards poses a potential health risk.

What You Should Do

  1. This recall affects Clindamycin HCl 300 mg capsules packaged in 30-count blister cards under the RemedyRepack Inc. brand (NDC 70518-3772-00).
  2. Identify if your product is affected by checking for lot numbers J0826722-121624 (expiring 12/31/2025), J0820365-111324 (expiring 11/30/2025), or J0814691-101624 (expiring 10/31/2025).
  3. If you have health concerns, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact RemedyRepack Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Clindamycin HCl (300 mg)
Variants: 300 mg, Capsule, 30-count blister cards
Lot Numbers:
J0826722-121624 (Exp. 12/31/2025)
J0820365-111324 (Exp. 11/30/2025)
J0814691-101624 (Exp. 10/31/2025)
NDC:
70518-3772-00

Repackaged by RemedyRepack Inc. in Indiana, PA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96627
Status: Active
Manufacturer: RemedyRepack Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 1,858 30-count blister cards
Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.