DOXYCYCLINE

Generic: DOXYCYCLINE

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Manufacturer

ORALRoute

DOXYCYCLINEActive Substance

2011-12-20Original Approval

DOXYCYCLINE is FDA application ANDA091605, sponsored by HERITAGE. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-05-13

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 014

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life

Class II2022-04-13

Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma

cGMP deviations: Temperature abuse

Class II2018-07-24

Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. E

Failed Dissolution Specifications:

Class II2018-07-24

Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Ea

Failed Dissolution Specifications:

Class II2022-01-26

Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryla

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi

Class II2020-03-13

Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practic

Class II2025-09-29

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alphar

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution spe

Class II2018-08-01

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: A

Failed Dissolution Specifications: Out of specification result for the dissolution test.

Class II2022-04-13

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50

cGMP deviations: Temperature abuse

Class II2020-03-13

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 0

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practic

DOXYCYCLINE

Recalls

Top Reported Reactions