Class II · Moderate risk Ongoing
Doxycycline Hyclate Tablets
Reason Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Doxycycline Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
What was recalled
Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- NDC code
- 63304-615-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1032-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Doxycycline recalls
See all
Class II · Moderate risk Terminated
Doxycycline
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Doxycycline Hyclate Tablets
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Doxycycline Capsules
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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