CLASS II Drug recall · Reported 3 Jun 2020 · FDA Enforcement Report
Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward Columbus
West-Ward Columbus is recalling Doxycycline Hyclate Tablets USP, 100 mg, distributed nationwide in the US. The recall was initiated on 13 May 2020 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-1274-2020
- FDA event ID
- 85555
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Brand
- Doxycycline Hyclate
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2020
- FDA classified
- 26 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 13 May 2020 | Recall initiated by company | |
| 26 May 2020 | Classified by FDA | +13 days |
| 3 Jun 2020 | 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
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Which lots are affected?
Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B, 71853A, Exp 6/2021
Where was it sold?
USA 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 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 26 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 West-Ward Columbus
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward ColumbusLeucovorin Calcium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS III | Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
Other Doxycycline Hyclate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP 100 mg* recalledDoxycycline | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP, 100 mg carton each blister pack recalledDoxycycline Hyclate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP, 100 mg per carton (3 recalledDoxycycline Hyclate | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP, 100 mg recalledDoxycycline Hyclate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate tablets USP, 100 mg recalledDoxycycline | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |