Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Yes — there is an active recall. 1 ongoing FDA recall mention Doxycycline (31 total). Check the affected lots below.
Most common reason: Dissolution failure (10 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Doxycycline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Failed dissolution specifications
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Failed Dissolution Specifications
Failed Dissolution Specifications:
Failed Dissolution Specifications:
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
CGMP Deviations
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Lack of Processing Controls
Labeling: Wrong Bar Code
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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