CLASS III Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report
Doxycycline, USP Capsules 40 mg recalled by Galderma Laboratories
Galderma Laboratories is recalling Doxycycline, USP Capsules 40 mg, distributed nationwide in the US. The recall was initiated on 19 May 2016 and the FDA has classified it as Class III.
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-1031-2016
- FDA event ID
- 74209
- Recalling firm
- Galderma Laboratories, Fort Worth, TX
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 May 2016
- FDA classified
- 14 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 19 May 2016 | Recall initiated by company | |
| 14 Jun 2016 | Classified by FDA | +26 days |
| 22 Jun 2016 | 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
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Doxycycline, USP Capsules 40 mg recalled?
Yes. Galderma Laboratories recalled Doxycycline, USP Capsules 40 mg on 19 May 2016. The recall is Class III and its status is Terminated. Recall number D-1031-2016.
Why was it recalled?
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Which lots are affected?
Lot #: 1496059A, Expiry: 08/31/2017; Lot #: AD9848A, Expiry: 11/30/2017
Where was it sold?
U.S. Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Galderma Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Capex Shampoo (fluocinolone acetonide), Topical Shampoo recalled | Galderma Laboratories | Potency & Assay | Nationwide |