CLASS II Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report

Doxycycline Hyclate USP Tablets, 100 mg recalled

PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate USP Tablets, 100 mg, distributed nationwide in the US. The recall was initiated on 7 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) D17D29, L17C73, F18E73, Exp. 1/31/19; b) H17D70, K17F66, G18F26, Exp. 1/31/19; c) C18G26, F18E36, Exp. 1/31/19; d) F18A85, Exp. 1/31/19; e) K17B44, K17E29, L17D93, Exp. 1/31/19; E17B88, Exp. 5/31/19; H17A52, H17D67, Exp. 7/31/19; f) E17B01, E17E83, Exp. 5/31/19; F17C99, Exp. 6/30/19; G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, Exp. 7/31/19; g) E17E27, Exp. 1/31/19, I17A33, G17D62, Exp. 7/31/19; h) E17B35, E17D90, Exp. 5/31/19, F17C13, Exp. 6/30/19, G17B25, H17C58, Exp. 7/31/19; i) G17D59, Exp. 7/31/19; j) I17A69, G17D58, Exp. 7/31/19; k) G17D56, Exp. 7/31/19.

NDC55289-866

UPC0355289866954

Quantity recalled6,641 bottles

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-1127-2018
FDA event ID: 80791
Recalling firm: PD-Rx Pharmaceuticals, Oklahoma City, OK
Brand: Doxycycline
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 7 Aug 2018
FDA classified: 24 Aug 2018
Reported: 5 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

7 Aug 2018	Recall initiated by company
24 Aug 2018	Classified by FDA	+17 days
5 Sep 2018	Published in enforcement report	+12 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: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

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 USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

Which lots are affected?

Lot #: a) D17D29, L17C73, F18E73, Exp. 1/31/19; b) H17D70, K17F66, G18F26, Exp. 1/31/19; c) C18G26, F18E36, Exp. 1/31/19; d) F18A85, Exp. 1/31/19; e) K17B44, K17E29, L17D93, Exp. 1/31/19; E17B88, Exp. 5/31/19; H17A52, H17D67, Exp. 7/31/19; f) E17B01, E17E83, Exp. 5/31/19; F17C99, Exp. 6/30/19; G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, Exp. 7/31/19; g) E17E27, Exp. 1/31/19, I17A33, G17D62, Exp. 7/31/19; h) E17B35, E17D90, Exp. 5/31/19, F17C13, Exp. 6/30/19, G17B25, H17C58, Exp. 7/31/19; i) G17D59, Exp. 7/31/19; j) I17A69, G17D58, Exp. 7/31/19; k) G17D56, Exp. 7/31/19.

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 PD-Rx Pharmaceuticals

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10 May 2023Drug	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
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10 May 2023Drug	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
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Other Doxycycline Hyclate recalls

All 15

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Doxycycline Hyclate Tablets, USP 100 mg* recalledDoxycycline	Acella Pharmaceuticals	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Doxycycline Hyclate Tablets, USP, 100 mg carton each blister pack recalledDoxycycline Hyclate	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
17 Jun 2020Drug	CLASS II	Doxycycline Hyclate Tablets, USP, 100 mg per carton (3 recalledDoxycycline Hyclate	American Health Packaging	Potency & Assay	Nationwide
10 Jun 2020Drug	CLASS II	Doxycycline Hyclate Tablets, USP, 100 mg recalledDoxycycline Hyclate	The Harvard Drug Group	Potency & Assay	Nationwide
3 Jun 2020Drug	CLASS II	Doxycycline Hyclate tablets USP, 100 mg recalledDoxycycline	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide