CLASS II ONGOING Drug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Doxycycline Hyclate Tablets, USP 100 mg* recalled
Acella Pharmaceuticals is recalling Doxycycline Hyclate Tablets, USP 100 mg*, distributed nationwide in the US. The recall was initiated on 29 Sep 2025 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-0014-2026
- FDA event ID
- 97716
- Recalling firm
- Acella Pharmaceuticals, Alpharetta, GA
- Brand
- Doxycycline
- Manufacturer
- Acella Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Sep 2025
- FDA classified
- 9 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 29 Sep 2025 | Recall initiated by company | |
| 9 Oct 2025 | Classified by FDA | +10 days |
| 15 Oct 2025 | 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: Stability testing found that the lot did not meet 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*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Which lots are affected?
Lot #: P24ZLK1, Exp 5/31/2027
Where was it sold?
Nationwide in the 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 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 Acella Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen | Acella Pharmaceuticals | Lead & Heavy Metals | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser recalledSodium Sulfacetamide 10 Sulfur 5 Cleanser | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads recalled | Acella Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP 100 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Phenytoin Sodium Injection, USP, 250 mg recalledPhenytoin Sodium | Acella Pharmaceuticals | Packaging Defects | Nationwide |
Other Doxycycline Hyclate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |