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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

Sun Pharmaceutical Industries, Inc.: Doxycycline Capsules Recalled for Manufacturing Practice Deviations

Agency Publication Date: March 18, 2020
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Summary

Approximately 172,944 bottles of Doxycycline Capsules (75 mg and 100 mg), a prescription antibiotic, are being recalled because they were not manufactured under Current Good Manufacturing Practice (CGMP) conditions. This recall includes 624 bottles of the 75 mg strength and 172,320 bottles of the 100 mg strength distributed nationwide. While no specific injuries or adverse health effects have been reported in this data, deviations from manufacturing standards can compromise the quality and safety of medication. Consumers should contact their healthcare provider or pharmacist regarding their medication and return any unused product to the place of purchase for a refund.

Risk

The drug was not manufactured according to required quality standards, which could lead to potential issues with the medication's purity, potency, or overall quality. Using a medication that does not meet manufacturing standards could result in ineffective treatment of infections or unexpected side effects.

What You Should Do

  1. Check your prescription bottle for Doxycycline Capsules, USP, 75 mg (100-count, NDC 63304-615-01) with lot number AA39490 and expiration date 03/2021.
  2. Check your prescription bottle for Doxycycline Capsules, USP, 100 mg (50-count, NDC 63304-616-50) with any of the following lot numbers: 3983720 (Exp 10/2020); 3990461, 3990464, 3990465, 3990466, 3990470 (Exp 11/2020); AA42499, AA42510, AA44468, AA44470 (Exp 04/2021); AA55073, AA55074, AA55075 (Exp 05/2021); or AA61486 (Exp 06/2021).
  3. Contact your healthcare provider or pharmacist immediately to discuss whether you should continue taking the medication or if you need a replacement prescription.
  4. Return any unused capsules from the affected lots to the pharmacy where you purchased them for a refund.
  5. Contact the manufacturer, Sun Pharmaceutical Industries, Inc., for further instructions or questions regarding this recall.
  6. For additional information, 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

Healthcare guidance 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: Doxycycline Capsules, USP, 75 mg (100-count bottle)
Model:
NDC 63304-615-01
Recall #: D-1032-2020
Lot Numbers:
AA39490 (Exp 03/2021)
Date Ranges: 03/2021
Product: Doxycycline Capsules, USP, 100 mg (50-count bottle)
Model:
NDC 63304-616-50
Recall #: D-1033-2020
Lot Numbers:
3983720 (Exp 10/2020)
3990461 (Exp 11/2020)
3990464 (Exp 11/2020)
3990465 (Exp 11/2020)
3990466 (Exp 11/2020)
3990470 (Exp 11/2020)
AA42499 (Exp 04/2021)
AA42510 (Exp 04/2021)
AA44468 (Exp 04/2021)
AA44470 (Exp 04/2021)
AA55073 (Exp 05/2021)
AA55074 (Exp 05/2021)
AA55075 (Exp 05/2021)
AA61486 (Exp 06/2021)
Date Ranges: 10/2020, 11/2020, 04/2021, 05/2021, 06/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85230
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: Pharmacies nationwide
Manufactured In: United States
Units Affected: 2 products (624 bottles; 172,320 bottles)
Distributed To: Nationwide

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.