Class II · Moderate risk
Doxycycline Hyclate Tablets
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.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.
Affected NDC
63304-0616-50
Compare with the code on your package — it is the most precise check available.
Drug: Doxycycline Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Doxycycline NDC 63304-0616 |
100 mg/1 | Capsule Oral |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- NDC code
- 63304-616-50
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1033-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Doxycycline recalls
See all
Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Doxycycline Hyclate Tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Doxycycline Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by Sun Pharmaceutical Industries, Inc.
All 2020 recalls
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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