CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Doxycycline Hyclate Tablets, USP, 100 mg recalled
Major Pharmaceuticals is recalling Doxycycline Hyclate Tablets, USP, 100 mg, distributed nationwide in the US. The recall was initiated on 30 Jul 2018 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-1026-2018
- FDA event ID
- 80659
- Recalling firm
- Major Pharmaceuticals, Livonia, MI
- Brand
- Doxycycline Hyclate
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2018
- FDA classified
- 2 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 30 Jul 2018 | Recall initiated by company | |
| 2 Aug 2018 | Classified by FDA | +3 days |
| 8 Aug 2018 | Published in enforcement report | +6 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 Specifications
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, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04
Where it was distributed
Nationwide USA
Questions about this recall
Is Doxycycline Hyclate Tablets, USP, 100 mg recalled?
Yes. Major Pharmaceuticals recalled Doxycycline Hyclate Tablets, USP, 100 mg on 30 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-1026-2018.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot: 71545AA, exp 7/2019
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 Major Pharmaceuticals
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg 0150 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 50 mcg 050 mg) dose blisters recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg 0125 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg 0112 mg) recalledLevothyroxine Sodium | Major Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 25 mcg 025 mg) dose blisters recalledLevothyroxine Sodium | Major Pharmaceuticals | 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 x recalledDoxycycline Hyclate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Doxycycline Hyclate Tablets, USP, 100 mg per carton (3 x 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 |