CLASS II Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Doxycycline Capsules, USP 100 mg recalled by Cardinal Healthcare
Cardinal Healthcare is recalling Doxycycline Capsules, USP 100 mg, distributed nationwide in the US. The recall was initiated on 26 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0178-2024
- FDA event ID
- 89450
- Recalling firm
- Cardinal Healthcare, Dublin, OH
- Brand
- Doxycycline
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +699 days |
| 3 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product as listed by the FDA
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
Where it was distributed
Nationwide USA
Questions about this recall
Is Doxycycline Capsules, USP 100 mg recalled?
Yes. Cardinal Healthcare recalled Doxycycline Capsules, USP 100 mg on 26 Jan 2022. The recall is Class II and its status is Terminated. Recall number D-0178-2024.
Why was it recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which lots are affected?
Batch G104819
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardinal Healthcare
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|---|---|---|---|---|---|
| Drug | CLASS II | Albuterol Sulfate HFA Inhalation Aerosol recalled by Cardinal HealthcareAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Albuterol Sulfate IN 90MCG per actuation, 200 Metered Inhalations recalledAlbuterol Sulfate | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Folic Acid Tablets, USP, 1MG recalled by Cardinal HealthcareFolic Acid | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Citalopram Tablets, USP, 20MG recalled by Cardinal HealthcareCitalopram | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Jardiance (empagliflozin tablets), 25 mg (3 blister cards with each) recalledJardiance | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
Other Doxycycline recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Doxycycline Capsules, USP, 100 mg recalled by Mckesson Medical-SurgicalDoxycycline | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxycycline Capsules, USP, 100 mg recalledDoxycycline | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxycycline Capsules, USP, 75 mg recalledDoxycycline | Sun Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |